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Účinnost reduktoru koronárního sinu u pacientů s refrakterní anginou pectoris II (COSIRA-II)

25. září 2026 aktualizováno: 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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

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

Typ studie

Intervenční

Zápis (Odhadovaný)

380

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Rameno 1 (léčebné rameno): Implantace zařízení Reducer
Přístroj: Arm 1: treatment with Shockwave Reducer

Shockwave reducer is an implantable device being evaluated for the alleviation of refractory angina symptoms
Falešný srovnávač: Rameno 2 (falešné ovládací rameno): Ovládání (bez implantace zařízení)
Jiný: Arm 2 (control): Implantation procedure with no device implanted

No device is implanted
Jiný: Rameno 3 (nezaslepené, nerandomizované): Jednoramenný registr
Přístroj: Arm 3 (unblinded, non-randomized): Single arm registry

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

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Co-Primary Effectiveness Endpoints
Časové okno: 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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Canadian Cardiovascular Society (CCS) Angina Score
Časové okno: 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
Časové okno: 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

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Canadian Cardiovascular Society (CCS) Angina Score
Časové okno: 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
Časové okno: 6 and 12 months

Angina frequency and burden compared to baseline
6 and 12 months
Activity
Časové okno: 6 and 12 months

Measure of activity assessed by actigraphy compared to baseline
6 and 12 months
Exercise Tolerance Testing
Časové okno: 6 and 12 months

Change in ETT parameters compared to baseline
6 and 12 months
Exercise Tolerance Testing
Časové okno: 12 months

Change in total exercise duration compared to baseline
12 months
Doctor Visits
Časové okno: 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
Časové okno: 6 and 12 months

Total exercise duration
6 and 12 months
Seattle Angina Questionnaire (SAQ) Score
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Shockwave Medical, Inc.

Vyšetřovatelé

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

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

4. ledna 2022

Primární dokončení (Odhadovaný)

1. července 2027

Dokončení studie (Odhadovaný)

1. ledna 2032

Termíny zápisu do studia

První předloženo

8. října 2021

První předloženo, které splnilo kritéria kontroly kvality

21. října 2021

První zveřejněno (Aktuální)

1. listopadu 2021

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

30. září 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

25. září 2026

Naposledy ověřeno

1. září 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 022-REDUCLN-002

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ano

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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