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Eficacia del reductor del seno coronario en pacientes con angina refractaria II (COSIRA-II)

25 de septiembre de 2026 actualizado por: Shockwave Medical, Inc.

To demonstrate the safety and effectiveness of the Shockwave Reducer for treatment of patients with refractory angina pectoris treated with maximally tolerated guideline-directed medical therapy who demonstrate objective evidence of reversible myocardial ischemia in the distribution of the left coronary artery and who are deemed unsuitable for revascularization. A non-randomized single-arm registry will further assess the safety and effectiveness of the Shockwave Reducer in selected subjects with reversible myocardial ischemia in the distribution of the right coronary artery and who are deemed unsuitable for revascularization, subjects without documented obstructive coronary disease and abnormal coronary flow reserve (ANOCA), and subjects who cannot complete an exercise tolerance test due to lower limb amputation (above the ankle) or other physiologic condition with documented chronic mobility or balance issues that require the use of a walking aid.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

The COSIRA-II study is a multicenter, randomized (1:1 ratio), double-blinded, sham-controlled clinical trial.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

380

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Canadá
    • British Columbia
      • Vancouver, British Columbia, Canadá, V521M9
        • Reclutamiento
        • Vancouver General Hospital
        • Contacto:
        • Investigador principal:
          • David Wood
    • Ontario
      • Ottawa, Ontario, Canadá, K1y4W7
        • Reclutamiento
        • University of Ottawa Heart Institute
        • Contacto:
        • Investigador principal:
          • Mariano Labinaz
      • Toronto, Ontario, Canadá, M5G 2C4
        • Reclutamiento
        • Toronto General Hospital (UHN)
        • Contacto:
        • Investigador principal:
          • Vladimir Dzavik
    • Quebec
      • Montreal, Quebec, Canadá, H2X 0C1
      • Québec, Quebec, Canadá, G1V4G5
        • Reclutamiento
        • IUCPQ-Ulaval
        • Contacto:
        • Investigador principal:
          • Jean-Michael Paradis, MD
  • Estados Unidos
    • Arizona
      • Phoenix, Arizona, Estados Unidos, 85054
        • Reclutamiento
        • Mayo Clinic
        • Investigador principal:
          • David Fortuin, MD
        • Contacto:
      • Scottsdale, Arizona, Estados Unidos, 85258
        • Reclutamiento
        • HonorHealth Research Institute
        • Investigador principal:
          • Taral Patel, MD
        • Contacto:
      • Tucson, Arizona, Estados Unidos, 85724
        • Reclutamiento
        • University of Arizona Sarver Heart Center
        • Investigador principal:
          • Michel Corban, MD
        • Contacto:
    • California
      • Long Beach, California, Estados Unidos, 90822
        • Retirado
        • Long Beach VA Medical Center
      • Los Angeles, California, Estados Unidos, 90048
        • Reclutamiento
        • Cedars-Sinai
        • Investigador principal:
          • Suhail Dohad, MD
        • Contacto:
      • Los Angeles, California, Estados Unidos, 90033
        • Reclutamiento
        • USC Keck School of Medicine
        • Contacto:
        • Investigador principal:
          • Jubin Joseph
      • San Diego, California, Estados Unidos, 92037
        • Reclutamiento
        • UCSD
        • Investigador principal:
          • Ehtisham Mahmud, MD
        • Contacto:
      • San Francisco, California, Estados Unidos, 94115
        • Reclutamiento
        • Kaiser Permanente San Francisco
        • Contacto:
        • Investigador principal:
          • Gopi Manthripragada
      • San Francisco, California, Estados Unidos, 94117
        • Reclutamiento
        • UCSF
        • Investigador principal:
          • Yousif Ahmad
        • Contacto:
      • Thousand Oaks, California, Estados Unidos, 91360
        • Reclutamiento
        • Los Robles Hospital and Medical Center
        • Investigador principal:
          • Saibal Kar, MD
        • Contacto:
    • Colorado
      • Littleton, Colorado, Estados Unidos, 80120
        • Reclutamiento
        • South Denver Cardiology Associates
        • Contacto:
        • Investigador principal:
          • Lee McDonald
    • Connecticut
      • New Haven, Connecticut, Estados Unidos, 06519
        • Reclutamiento
        • Yale University
        • Contacto:
        • Investigador principal:
          • Samit Shah, MD
    • District of Columbia
      • Washington D.C., District of Columbia, Estados Unidos, 20010
        • Reclutamiento
        • MedStar Cardiovascular Research Network
        • Investigador principal:
          • Hayder Hashim, MD
        • Contacto:
    • Florida
      • Gainesville, Florida, Estados Unidos, 32605
        • Reclutamiento
        • The Cardiac and Vascular Institute
        • Investigador principal:
          • Matheen Khuddus, MD
        • Contacto:
      • Jacksonville, Florida, Estados Unidos, 32209
        • Reclutamiento
        • UF Health Jacksonville
        • Investigador principal:
          • Daniel Soffer
        • Contacto:
      • Miami Beach, Florida, Estados Unidos, 33140
        • Reclutamiento
        • Mount Sinai Miami
        • Contacto:
        • Investigador principal:
          • Nirat Beohar
      • Naples, Florida, Estados Unidos, 34102
        • Reclutamiento
        • NCH Healthcare - Naples
        • Contacto:
        • Investigador principal:
          • Frank Adam
      • Pensacola, Florida, Estados Unidos, 32504
        • Reclutamiento
        • Ascension Sacred Heart
        • Investigador principal:
          • Rohit Amin
        • Contacto:
      • Tallahassee, Florida, Estados Unidos, 32308
        • Reclutamiento
        • Tallahassee Research Institute
        • Investigador principal:
          • Thomas Noel, MD
        • Contacto:
      • Tampa, Florida, Estados Unidos, 33606
        • Reclutamiento
        • Tampa General - USF Cardiology
        • Contacto:
        • Investigador principal:
          • Fadi Matar
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30308
        • Reclutamiento
        • Emory Hospital
        • Contacto:
        • Investigador principal:
          • William Nicholson
      • Atlanta, Georgia, Estados Unidos, 30342
        • Retirado
        • Northside Hospital
      • Gainsville, Georgia, Estados Unidos, 30501
        • Reclutamiento
        • Northeast Georgia
        • Investigador principal:
          • Olga Toleva
        • Contacto:
      • Marietta, Georgia, Estados Unidos, 30062
        • Reclutamiento
        • Wellstar Kennestone Hospital
        • Investigador principal:
          • Salvatore Mannino
        • Contacto:
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60611
        • Reclutamiento
        • Northwestern University
        • Investigador principal:
          • Dan Schimmel
        • Contacto:
      • Springfield, Illinois, Estados Unidos, 62781
        • Reclutamiento
        • Southern Illinois University
        • Investigador principal:
          • Abdul Moiz Hafiz
        • Contacto:
    • Indiana
      • Carmel, Indiana, Estados Unidos, 46920
        • Reclutamiento
        • Ascension St. Vincent Heart Center
        • Contacto:
        • Investigador principal:
          • Bryce Lynn
      • Munster, Indiana, Estados Unidos, 46321
        • Reclutamiento
        • Community Hospital - Munster
        • Investigador principal:
          • Dean Ferrera
        • Contacto:
          • Magdelena Borzecka
          • Número de teléfono: 2194007325
    • Kansas
      • Kansas City, Kansas, Estados Unidos, 66160
        • Reclutamiento
        • University of Kansas Medical Center
        • Investigador principal:
          • Prasad Gunasekaran
        • Contacto:
          • Kartik Munshi
          • Número de teléfono: 9139456445
          • Correo electrónico: kmunshi@kumc.edu
      • Wichita, Kansas, Estados Unidos, 67226
        • Retirado
        • Cardiovascular Research Institute of Kansas
    • Kentucky
      • Louisville, Kentucky, Estados Unidos, 40202
        • Reclutamiento
        • University of Louisville
        • Contacto:
        • Investigador principal:
          • Yuvraj Chowdhury
    • Louisiana
      • Houma, Louisiana, Estados Unidos, 70360
        • Reclutamiento
        • Cardiovascular Institute of the South
        • Investigador principal:
          • Vinod Nair
        • Contacto:
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02114
        • Reclutamiento
        • Massachusetts General Hospital
        • Investigador principal:
          • Farouc Jaffer, MD
        • Contacto:
      • Boston, Massachusetts, Estados Unidos, 02120
        • Reclutamiento
        • Brigham and Women's Hospital
        • Investigador principal:
          • Kevin Croce, MD
        • Contacto:
        • Contacto:
      • Springfield, Massachusetts, Estados Unidos, 01199
        • Reclutamiento
        • Baystate Medical Center
        • Investigador principal:
          • Amir Lotfi, MD
        • Contacto:
    • Michigan
      • Ann Arbor, Michigan, Estados Unidos, 48109
        • Reclutamiento
        • University of Michigan
        • Contacto:
        • Investigador principal:
          • Brett Wanamaker, MD
      • Detroit, Michigan, Estados Unidos, 48202
        • Reclutamiento
        • Henry Ford Hospital
        • Investigador principal:
          • Gerald Koenig
        • Contacto:
          • Melanee Schimmel
          • Número de teléfono: 3139167614
          • Correo electrónico: mschimm2@hfhs.org
      • Detroit, Michigan, Estados Unidos, 48236
        • Reclutamiento
        • Henry Ford St. Johns
        • Investigador principal:
          • Edouard Daher
        • Contacto:
          • Renee Bess
          • Número de teléfono: 3133434811
          • Correo electrónico: rbess1@hfhs.org
      • Grand Rapids, Michigan, Estados Unidos, 59403
        • Reclutamiento
        • Corewell Health
        • Investigador principal:
          • Devraj Sukul
        • Contacto:
      • Southfield, Michigan, Estados Unidos, 48075
        • Reclutamiento
        • Henry Ford Providence
        • Investigador principal:
          • Shukri David, MD
        • Contacto:
    • Minnesota
      • Minneapolis, Minnesota, Estados Unidos, 55407
        • Reclutamiento
        • Minneapolis Heart Institute Foundation
        • Investigador principal:
          • Jay Traverse
        • Contacto:
      • Rochester, Minnesota, Estados Unidos, 55905
        • Reclutamiento
        • Mayo Clinic
        • Contacto:
        • Investigador principal:
          • Abhiram Prasad, MD
    • Mississippi
      • Jackson, Mississippi, Estados Unidos, 39216
        • Reclutamiento
        • Jackson Heart Clinic
        • Investigador principal:
          • William Crowder
        • Contacto:
      • Tupelo, Mississippi, Estados Unidos, 38801
        • Retirado
        • Cardiology Associates of North Mississippi
    • Missouri
      • Kansas City, Missouri, Estados Unidos, 64111
        • Reclutamiento
        • Saint Luke's Hospital
        • Investigador principal:
          • Anthony Hart, MD
        • Contacto:
          • Lisa Lacy
          • Número de teléfono: 816-932-7528
          • Correo electrónico: lisa.lacy@bjc.org
    • New Jersey
      • Hackensack, New Jersey, Estados Unidos, 07601
        • Reclutamiento
        • Hackensack University
        • Investigador principal:
          • Haroon Faraz
        • Contacto:
    • New York
      • New York, New York, Estados Unidos, 10021
        • Reclutamiento
        • Weill Cornell Medicine
        • Investigador principal:
          • Jai Khatri
        • Contacto:
      • New York, New York, Estados Unidos, 10032
        • Reclutamiento
        • Columbia University Medical Center/NYPH
        • Investigador principal:
          • Ajay Kirtane, MD
        • Contacto:
      • New York, New York, Estados Unidos, 10003
        • Reclutamiento
        • Mount Sinai Medical Center
        • Investigador principal:
          • Samin Sharma, MD
        • Contacto:
      • New York, New York, Estados Unidos, 10010
      • Roslyn, New York, Estados Unidos, 11576
        • Reclutamiento
        • St. Francis Hospital
        • Investigador principal:
          • Evan Shlofmitz, MD
        • Contacto:
    • North Carolina
      • Charlotte, North Carolina, Estados Unidos, 28204
    • Ohio
      • Cincinnati, Ohio, Estados Unidos, 45219
      • Cleveland, Ohio, Estados Unidos, 44195
        • Reclutamiento
        • Cleveland Clinic
        • Investigador principal:
          • Jaikirshan Khatri, MD
        • Contacto:
      • Columbus, Ohio, Estados Unidos, 43210
        • Reclutamiento
        • The Ohio State University
        • Investigador principal:
          • Scott Lilly, MD
        • Contacto:
    • Oklahoma
      • Tulsa, Oklahoma, Estados Unidos, 74104
        • Reclutamiento
        • Ascension St. John
        • Investigador principal:
          • Thomas Kalapura
        • Contacto:
    • Oregon
      • Portland, Oregon, Estados Unidos, 97225
        • Reclutamiento
        • Providence Heart Institute
        • Investigador principal:
          • Jason Wollmuth, MD
        • Contacto:
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Estados Unidos, 15212
        • Reclutamiento
        • Allegheny General Hospital
        • Investigador principal:
          • Mithun Chakravarthy
        • Contacto:
    • Tennessee
      • Nashville, Tennessee, Estados Unidos, 37203
        • Reclutamiento
        • TriStar Centennial Medical Center
        • Investigador principal:
          • Brian Jefferson, MD
        • Contacto:
      • Nashville, Tennessee, Estados Unidos, 37232
        • Reclutamiento
        • Vanderbilt Heart
        • Investigador principal:
          • Nadia Sutton, MD
        • Contacto:
    • Texas
      • Austin, Texas, Estados Unidos, 78705
        • Reclutamiento
        • Ascension Texas Cardiovascular
        • Investigador principal:
          • Mark Gajjar
        • Contacto:
      • Fort Worth, Texas, Estados Unidos, 76104
      • Houston, Texas, Estados Unidos, 77030
        • Reclutamiento
        • University of Texas Health Science Center at Houston
        • Contacto:
        • Investigador principal:
          • Salman Arain, MD
      • Houston, Texas, Estados Unidos, 77030
        • Reclutamiento
        • Houston Methodist
        • Contacto:
        • Investigador principal:
          • Alpesh Shah
      • Houston, Texas, Estados Unidos, 77030
        • Reclutamiento
        • Texas Heart Institute
        • Investigador principal:
          • Emerson Perin
        • Contacto:
      • Houston, Texas, Estados Unidos, 77004
        • Retirado
        • HCA Houston Healthcare Medical Center
      • Plano, Texas, Estados Unidos, 75093
        • Reclutamiento
        • The Heart Hospital Baylor Plano
        • Investigador principal:
          • Srini Potluri
        • Contacto:
      • San Antonio, Texas, Estados Unidos, 78229
    • Virginia
      • Charlottesville, Virginia, Estados Unidos, 22908
        • Reclutamiento
        • University of Virginia
        • Investigador principal:
          • Rajan Patel
        • Contacto:
      • Norfolk, Virginia, Estados Unidos, 23507
        • Reclutamiento
        • Sentara Norfolk General Hospital
        • Investigador principal:
          • Paul Lavigne, MD
        • Contacto:
    • Wisconsin
      • Madison, Wisconsin, Estados Unidos, 53792
        • Reclutamiento
        • University of Wisconsin
        • Contacto:
        • Investigador principal:
          • Amish Raval
      • Milwaukee, Wisconsin, Estados Unidos, 53215
        • Reclutamiento
        • Advocate Aurora Research Institute
        • Contacto:
          • Sara Klien
        • Investigador principal:
          • Joaquin Solis
  • Reino Unido
      • Basildon, Reino Unido, SS16 5NL
        • Reclutamiento
        • Essex Cardiothoracic Centre
        • Contacto:
        • Investigador principal:
          • Thomas Keeble, MD
      • Birmingham, Reino Unido, B15 2GW
        • Reclutamiento
        • Queen Elizabeth Hospital Birmingham
        • Contacto:
        • Investigador principal:
          • Alex Zaphiriou, MD
      • Bristol, Reino Unido, BS2 8HW
        • Reclutamiento
        • Bristol Heart Institute
        • Contacto:
        • Investigador principal:
          • Ioannis Felekos, MD
      • Cambridge, Reino Unido, |CB2 0AY
        • Reclutamiento
        • Royal Papworth Hospital
        • Contacto:
        • Investigador principal:
          • Stephen Hoole, MD
      • Dorchester, Reino Unido, DT1 2JY
        • Reclutamiento
        • Dorset County Hospital NHS Foundation Trust
        • Contacto:
        • Investigador principal:
          • Fraser Witherow, MD
      • Kettering, Reino Unido, NN16 8UZ
        • Reclutamiento
        • Kettering General Hospital
        • Contacto:
        • Investigador principal:
          • Prashanth Raju, MD
      • Leicester, Reino Unido, LE3 9QP
        • Reclutamiento
        • Glenfield Hospital, Leicester
        • Contacto:
        • Investigador principal:
          • Bhavik Modi, MD
      • Liverpool, Reino Unido, L14 3PE
        • Reclutamiento
        • Liverpool Heart and Chest Hospital NHS Foundation Trust
        • Investigador principal:
          • Joel Giblett, MD
        • Contacto:
      • London, Reino Unido, SW3 6NP
        • Reclutamiento
        • Royal Brompton Hospital
        • Investigador principal:
          • Ranil De Silva, MD
        • Contacto:
      • London, Reino Unido, NW3 2QG
        • Reclutamiento
        • Royal Free Hospital
        • Contacto:
        • Investigador principal:
          • Gerry Coghlan, MD
      • London, Reino Unido, SE5 9RS
        • Reclutamiento
        • King's College Hospital
        • Contacto:
        • Investigador principal:
          • Jonathan Byrne, MD
      • London, Reino Unido, W12 0HS
        • Reclutamiento
        • Imperial College Healthcare NHS Trust
        • Contacto:
        • Investigador principal:
          • Rasha Al-Lamee, MD
      • London, Reino Unido, SE1 7EH
        • Reclutamiento
        • St. Thomas Hospital
        • Investigador principal:
          • Tiffany Patterson, MD
        • Contacto:
      • London, Reino Unido, E1 1FR
        • Reclutamiento
        • Barts Health Centre
        • Contacto:
        • Investigador principal:
          • Anthony Mathur, MD
      • London, Reino Unido, SW17 0QT
        • Reclutamiento
        • St. Georges University Hospital
        • Investigador principal:
          • James Spratt, MD
        • Contacto:
      • Newcastle upon Tyne, Reino Unido, NE7 7DN
        • Reclutamiento
        • Freeman Hospital
        • Contacto:
        • Investigador principal:
          • Bilal Bawamia, MD
      • Nottingham, Reino Unido, NG5
        • Reclutamiento
        • Nottingham University Hospital
        • Contacto:
        • Investigador principal:
          • Andrew Vanezis, MD
      • Oxford, Reino Unido, OX3 9DU
        • Reclutamiento
        • Oxford University Hospital
        • Contacto:
        • Investigador principal:
          • Giovanni De Maria, MD
      • Poole, Reino Unido, BH15 2JB
        • Reclutamiento
        • Royal Bournemouth Hospital
        • Contacto:
        • Investigador principal:
          • Peter O'Kane, MD
      • Taunton, Reino Unido, TA1 5DA
        • Reclutamiento
        • Musgrove Park Hospital
        • Contacto:
        • Investigador principal:
          • Mohammad Sahebjalal, MD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. Subject is older than 18 years of age
  2. Symptomatic coronary artery disease (CAD) with greater than or equal to 90 days of persistent refractory angina pectoris classified as CCS Grade III or IV despite maximally tolerated guideline directed medical therapy as determined by the local heart team and confirmed by a Central Screening Eligibility Committee Note: subjects may also have exertional dyspnea, but the symptoms that limit activity must be anginal in nature (including chest pain, pressure, heaviness, discomfort, with or without radiation to the neck, jaw, shoulders, arms, or other location) and not dyspnea
  3. Must have attempted treatment with the maximally tolerated dose of at least three of the four (preferably all four) approved classes of anti-anginal agents: long-acting nitrates, calcium channel blockers (either a dihydropyridine or a non-dihydropyridine), beta blockers, and ranolazine. The regimen must be stable for at least 30 days prior to enrollment, must remain stable from enrollment to randomization, and there must be no intent to change the medical regimen for at least 12 months after randomization Note: If the dose of a medication was increased or decreased for a temporary period and then returned to the original dose, which will then be continued for at least 12 months after randomization, the subject may be immediately enrolled without needing to otherwise requalify
  4. Subject has either no treatment options for revascularization by coronary artery bypass grafting or by percutaneous coronary intervention, or is otherwise unsuitable or high risk for revascularization as determined by the local heart team, and confirmed by a Central Screening Eligibility Committee
  5. Evidence of either exercise or pharmacologically induced reversible ischemia severity by stress echo, nuclear study, PET, perfusion MRI, CT perfusion, FFR-CT, FFR, iFR, or other non-hyperemic FDA approved tests (such as diastolic hyperaemia free ratio [DRF] or resting full-cycle ratio [RFR] in the distribution of the left coronary artery (LCA), performed within 12 months prior to enrollment Note: If the subject has evidence of ischemia in both the LCA and RCA distributions, the extent of ischemia must be greater in the LCA distribution Note: The qualifying assessment must be performed after any myocardial infarction, CABG, or successful PCI within the prior 12 months. For subjects with multiple assessments, the one performed closest to enrollment will serve as the qualifying study
  6. Functional limitation due to refractory angina as defined by a modified Bruce exercise tolerance test duration of greater than or equal to 2 minutes but less than or equal to 10 minutes, performed while the subject is maintained on their stable regimen of maximally tolerated doses of anti-anginal medications Note: The ETT variability must be less than 20% between last two ETTs performed.
  7. Left ventricular ejection fraction (LVEF) greater than or equal to 30% within the 12-months prior to enrollment Note: The LVEF must be reassessed after any intervening myocardial infarction. For subjects with multiple assessments, the most recent LVEF assessment is used as the qualifying test.
  8. Subject is willing and able to sign informed consent
  9. Subject is willing to comply with the specified follow-up evaluations

Angiographic Inclusion Criteria:

1) Three-vessel coronary angiography performed within 12 months prior to enrollment demonstrating obstructive CAD (visually estimated diameter stenosis of ≥70% or ≥50% - <70% with fractional flow reserve (FFR) value of ≤0.80 or an iFR or other FDA-approved/cleared non-hyperemic physiological assessment (such as DFR or RFR) of ≤0.89 in one or more lesions) in the left coronary artery (main epicardial vessels or branches) that is not suitable for and will not be treated with PCI or CABG as determined by the local heart team Note: The qualifying 3-vessel angiogram must be performed after any myocardial infarction, PCI, or CABG within the 12 months prior to enrollment. For patients with multiple 3-vessel angiograms, the one performed closest to enrollment will serve as the qualifying study

Exclusion Criteria:

  1. Recent (within 30 days prior to enrollment) troponin or CKMB positive acute coronary syndrome (NSTEMI or STEMI) Note: subjects with an elevated troponin or CKMB without acute coronary syndrome may still be enrolled

  2. Recent successful revascularization by either CABG or PCI within six months prior to enrollment

    Note: Successful revascularization is defined as any CABG procedure, or any PCI procedure with a reduction of one or more lesions to <50% diameter stenosis

    Note: Subjects with successful revascularization by either CABG or PCI that occurred less than six months prior to enrollment may still be approved for participation in the trial if revascularization was completed six months prior to procedure and CSEC approves subject participation

  3. Recent unsuccessful PCI (e.g., failed attempt to open a chronic total occlusion) within 30 days prior to enrollment

    Note: Subjects with unsuccessful PCI that occurred less than 30 days prior to enrollment may still be approved for participation in the trial if PCI was completed 30 days prior to procedure and CSEC approves subject participation

  4. The predominant manifestation of angina is dyspnea

    Note: some dyspnea may be present with exertion, but the predominant symptom that limits activity must be angina (i.e., chest pain, pressure, tightness, heaviness, or discomfort, with or without radiation to the neck, jaw, shoulders, arms, or other location)

  5. Has extra-coronary contributory causes of angina - e.g., untreated hyperthyroidism, untreated anemia (hgb <10 g/dL), uncontrolled hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg despite medications), atrial fibrillation with rapid ventricular response (consistently >100 bpm despite medications) or other tachyarrhythmia, severe aortic stenosis, hypertrophic cardiomyopathy with left ventricular outflow tract obstruction or asymmetric septal hypertrophy (concentric left ventricular hypertrophy is not an exclusion criterion), or epicardial vasospasm disease/coronary artery vasospasm (CAS)/vasospastic angina (VSA)

  6. NYHA Class III or IV heart failure (HF), decompensated HF or hospitalization due to HF during the 90 days prior to enrollment

  7. Life threatening rhythm disorders or any rhythm disorders that would require future placement of an internal defibrillator and/or pacemaker

  8. Severe chronic obstructive pulmonary disease (COPD) as indicated by a forced expiratory volume in one second (FEV1) that is less than 55% of the predicted value, or need for home daytime oxygen or oral steroids

  9. Severe valvular heart disease (any valve)

  10. Moderate or severe RV dysfunction by echocardiography

  11. Pacemaker electrode/lead is present in the coronary sinus

  12. A Class I indication is present for an implantable defibrillator or cardiac resynchronization therapy according to ACCF/AHA/HRS guidelines

  13. Recent implantation of a new pacemaker or defibrillator lead with electrode in the right atrium within 90 days of enrollment

  14. Chronic severe renal failure (estimated eGFR less than 30 mL/min/1.73m2 by the MDRD formula) or subjects on chronic dialysis

  15. Known allergy to stainless steel or nickel

  16. Any clinical condition that might interfere with the trial protocol or the subject's ability to be compliant with the trial protocol (e.g., active alcohol or drug abuse, dementia, magnetic resonances imaging (MRI) planned within 8 weeks of procedure)

  17. Currently enrolled in another investigational device or drug trial that has not reached its primary endpoint or that might clinically interfere with the current trial endpoints or procedures

  18. Pregnant or planning pregnancy within the next 12 months (women of reproductive potential must have a negative pregnancy test within 7 days of the procedure)

  19. Subject is part of a vulnerable population who, in the judgment of the investigator, is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.

  20. Inability to tolerate dual antiplatelet therapy for 6 months if not on a chronic oral anticoagulant, or inability to tolerate a P2Y12 inhibitor for at least 6 months if on a chronic oral anticoagulant

  21. Comorbidities limiting life expectancy to less than one year

  22. Subject is currently hospitalized for definite or suspected COVID-19

  23. Subject has previously been symptomatic with or hospitalized for COVID-19 and has been asymptomatic for <8 weeks prior to enrollment or has not returned to his or her prior baseline (pre-COVID-19) clinical condition

  24. Subject is asymptomatic but has had a positive PCR or antigen test for COVID-19 within the past 4 weeks prior to enrollment

Angiographic/Hemodynamic Exclusion Criteria:

1) Coronary anatomy amenable to revascularization of ischemic myocardial territory by either PCI or CABG with at least moderate likelihood of long-term alleviation of angina or angina equivalent symptoms, as per the assessment of the local heart team.

Note: If a pathway to coronary revascularization is present which, in the opinion of the local heart team, is reasonably low risk and reasonably likely to provide long-term symptom relief and the subject refuses the revascularization procedure, the patient is ineligible for randomization

Procedural Angiographic/Hemodynamic Randomization Exclusion Criteria:

  1. Mean right atrial pressure greater than 15 mmHg assessed during the final screening procedure for eligibility assessment and potential randomization
  2. Anomalous or abnormal CS anatomy (e.g., tortuosity, aberrant branch, persistent left superior vena cava [SVC]) as demonstrated by angiogram
  3. The CS diameter at the most proximal end of the planned implant region (2-4 cm distal to the coronary sinus ostium) is less than 9.5 mm or greater than 13.0 mm

Single-arm Registry (Unblinded, Non-Randomized Treatment Arm) Inclusion/Exclusion Criteria:

Subject can be included in the single-arm registry if they fall into one of the three categories with inclusions and exclusion criteria as described below.

Predominant right coronary disease subjects (RCA):

  1. Reversible ischemia: Subjects with evidence of either exercise or pharmacologically induced reversible ischemia by stress echo, nuclear study, PET, perfusion MRI, CT perfusion, FFR-CT, FFR, iFR, or other non-hyperemic FDA approved or cleared tests (such as DFR or RFR) in the distribution of the right coronary artery (RCA), performed within 12 months prior to enrollment.

    Note: If the subject has evidence of ischemia in both the LCA and RCA distributions, the extent of ischemia must be greater in the RCA distribution

    Note: The qualifying assessment must be performed after any myocardial infarction, CABG, or successful PCI within the prior 12 months. If the anti-anginal medication regimen is permanently changed after the assessment of ischemia, the test must be repeated. For subjects with multiple assessments, the one performed closest to enrollment will serve as the qualifying study

  2. Obstructive CAD: Three-vessel coronary angiography performed within the 12 months prior to enrollment demonstrating obstructive CAD (visually assessed diameter stenosis of ≥70% or ≥50% - <70% with fractional flow reserve (FFR) value of ≤0.80 or an iFR or other FDA-approved/cleared non-hyperemic physiological assessment (such as DFR or RFR) of ≤0.89 in one or more lesions) in the RCA (main epicardial vessels or branches) that is not suitable for and will not be treated with PCI or CABG as determined by the local heart team.

    Note: The qualifying assessment must be performed after any myocardial infarction, PCI or CABG within the prior 12 months. For subjects with multiple assessments, the one performed closest to enrollment will serve as the qualifying study

  3. In addition to the above inclusion criteria, subjects must meet all inclusion criteria (except clinical inclusion #5 and angiographic inclusion #1) and none of the exclusion criteria of the main randomized trial

Non-obstructive coronary artery disease subjects (ANOCA)

  1. Abnormal Coronary Flow Reserve (CFR): subjects must have either abnormal PET CFR (< 2.0), abnormal perfusion CMR (cardiac MRI) CFR (<1.85), or abnormal invasive CFR (<2.5) in at least one main epicardial coronary artery performed within 12 months prior to enrollment

    Note: Subjects may or may not have evidence of either exercise or pharmacologically induced reversible ischemia by stress echo, nuclear study, PET, perfusion MRI, or CT perfusion

  2. Non-obstructive CAD: subjects have non-obstructive coronary disease (estimated diameter stenosis in all coronary lesions is <50% and (if performed) FFR ≥0.81 or a non-hyperemic test is ≥0.90) demonstrated on three-vessel coronary angiography performed within the 12 months prior to enrollment. If an estimated diameter stenosis is ≥50% to <70%, the patient may still qualify if FFR ≥0.81 or a non-hyperemic test is ≥0.90 in that vessel. If both FFR and a non-hyperemic test are performed, both must be negative.

    Note: The qualifying 3-vessel angiogram must be performed after any myocardial infarction, PCI or CABG within the 12 months prior to enrollment. For patients with multiple 3-vessel angiograms, the one performed closest to enrollment will serve as the qualifying study

  3. In addition to the above inclusion criteria, subjects must meet all inclusion criteria (except clinical inclusion #5 and angiographic inclusion #1) and none of the exclusion criteria of the main randomized trial

Subjects unable to complete ETT

  1. Subjects must be unable to complete the required COSIRA-II exercise tolerance test due to lower limb amputation (above the ankle) or other physiologic condition with documented chronic mobility or balance issues that require the use of a walking aid (e.g., wheelchair, cane, rollator, crutches, or knee walker).
  2. In addition to the above inclusion criteria, subjects must meet all inclusion criteria (except clinical inclusion #6) and none of the exclusion criteria of the main randomized trial

Prior to inclusion in single-arm registry, all subjects will be reviewed by the Central Screening Eligibility Committee to ensure that they meet registry inclusion criteria and are not eligible for enrollment into the randomized study.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Brazo 1 (brazo de tratamiento): Implantación del dispositivo Reductor
Dispositivo: Arm 1: treatment with Shockwave Reducer

Shockwave reducer is an implantable device being evaluated for the alleviation of refractory angina symptoms
Comparador falso: Brazo 2 (brazo de control simulado): Control (sin implante de dispositivo)
Otro: Arm 2 (control): Implantation procedure with no device implanted

No device is implanted
Otro: Brazo 3 (no cegado, no aleatorizado): Registro de un solo brazo
Dispositivo: Arm 3 (unblinded, non-randomized): Single arm registry

Shockwave Reducer is an implantable device being evaluated for the alleviation of refractory angina symptoms

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Co-Primary Effectiveness Endpoints
Periodo de tiempo: 6 months

Change in total exercise duration in a modified Bruce treadmill exercise tolerance testing evaluation in the Treatment arm compared to Sham-control arm.

Change in SAQ clinical summary score assessed at 6 months post procedure compared to baseline in the Treatment arm compared to the Sham-control arm.
6 months
Primary Safety Endpoints
Periodo de tiempo: 6 months

The rate of occurrence of a composite of death, myocardial infarction (MI), pericardial effusion requiring surgical or percutaneous intervention, device embolization, or BARC 3 or 5 bleeding evaluation in the Treatment arm compared to the Sham-control arm.
6 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Canadian Cardiovascular Society (CCS) Angina Score
Periodo de tiempo: 6 months

Improvement by greater than or equal to 1 CCS angina grade. The CCS grading system for angina is a clinical tool used by doctors to assess the degree of severity of a patient's angina. Possible scores range from Class 0 (asymptomatic angina) to Class IV (angina at rest).
6 months
Canadian Cardiovascular Society (CCS) Angina Score
Periodo de tiempo: 6 months

Improvement by greater than or equal to 2 CCS angina grades. The CCS grading system for angina is a clinical tool used by doctors to assess the degree of severity of a patient's angina. Possible scores range from Class 0 (asymptomatic angina) to Class IV (angina at rest).
6 months

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Canadian Cardiovascular Society (CCS) Angina Score
Periodo de tiempo: 12 months, 2 years, 3 years, 4 years, and 5 years

Improvement by greater than or equal to 1 and greater than or equal to 2 CCS angina grades compared to baseline. The CCS grading system for angina is a clinical tool used by doctors to assess the degree of severity of a patient's angina. Possible scores range from Class 0 (asymptomatic angina) to Class IV (angina at rest).
12 months, 2 years, 3 years, 4 years, and 5 years
Angina Burden
Periodo de tiempo: 6 and 12 months

Angina frequency and burden compared to baseline
6 and 12 months
Activity
Periodo de tiempo: 6 and 12 months

Measure of activity assessed by actigraphy compared to baseline
6 and 12 months
Exercise Tolerance Testing
Periodo de tiempo: 6 and 12 months

Change in ETT parameters compared to baseline
6 and 12 months
Exercise Tolerance Testing
Periodo de tiempo: 12 months

Change in total exercise duration compared to baseline
12 months
Doctor Visits
Periodo de tiempo: 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years

Number of unplanned office visits due for angina, and any hospitalizations or emergency department visits (for angina, non-angina cardiovascular causes) post procedure compared to baseline
6 months, 12 months, 2 years, 3 years, 4 years, and 5 years
Exercise Tolerance Testing
Periodo de tiempo: 6 and 12 months

Total exercise duration
6 and 12 months
Seattle Angina Questionnaire (SAQ) Score
Periodo de tiempo: 6 month, 12 month, 2 years, 3 years, 4 years, and 5 years

Change in other Seattle Angina Questionnaire (SAQ) domain scores and clinical summary score at 6 months (primary endpoint), 12 month and annually post procedure compared to baseline. The Seattle Angina Questionnaire (SAQ) is a disease-specific questionnaire used to quantify patients' symptoms of angina and the extent to which their angina affects their functioning and quality of life. Possible scores range from 0 (daily angina) to 100 (no angina). Lower scores indicate worse angina symptoms.
6 month, 12 month, 2 years, 3 years, 4 years, and 5 years
Adverse Events
Periodo de tiempo: 30 day, 6 month, 12 month, 2 years, 3 years, 4 years, and 5 years

Number of deaths, myocardial infarctions, strokes, unplanned revascularization procedures in-hospital, at 30 days, 3 months, 6 months, 12 months and annually post procedure
30 day, 6 month, 12 month, 2 years, 3 years, 4 years, and 5 years

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Shockwave Medical, Inc.

Investigadores

  • Investigador principal: Timothy D Henry, MD, The Christ Hospital Health Network
  • Investigador principal: Gregg W Stone, MD, Mt. Sinai Heart Health

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

4 de enero de 2022

Finalización primaria (Estimado)

1 de julio de 2027

Finalización del estudio (Estimado)

1 de enero de 2032

Fechas de registro del estudio

Enviado por primera vez

8 de octubre de 2021

Primero enviado que cumplió con los criterios de control de calidad

21 de octubre de 2021

Publicado por primera vez (Actual)

1 de noviembre de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

30 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

25 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 022-REDUCLN-002

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

Sí

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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