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Efficacité du réducteur de sinus coronaire chez les patients atteints d'angor réfractaire II (COSIRA-II)

25 septembre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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

Type d'étude

Interventionnel

Inscription (Estimé)

380

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Bras 1 (bras de traitement) :Implantation du dispositif Reducer
Dispositif: Arm 1: treatment with Shockwave Reducer

Shockwave reducer is an implantable device being evaluated for the alleviation of refractory angina symptoms
Comparateur factice: Bras 2 (bras contrôle factice) : Contrôle (pas d'implantation de dispositif)
Autre: Arm 2 (control): Implantation procedure with no device implanted

No device is implanted
Autre: Bras 3 (sans insu, non randomisé) : Registre à un seul bras
Dispositif: Arm 3 (unblinded, non-randomized): Single arm registry

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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Co-Primary Effectiveness Endpoints
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Canadian Cardiovascular Society (CCS) Angina Score
Délai: 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
Délai: 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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Canadian Cardiovascular Society (CCS) Angina Score
Délai: 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
Délai: 6 and 12 months

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

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

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

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

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Shockwave Medical, Inc.

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

4 janvier 2022

Achèvement primaire (Estimé)

1 juillet 2027

Achèvement de l'étude (Estimé)

1 janvier 2032

Dates d'inscription aux études

Première soumission

8 octobre 2021

Première soumission répondant aux critères de contrôle qualité

21 octobre 2021

Première publication (Réel)

1 novembre 2021

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

30 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

25 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 022-REDUCLN-002

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Oui

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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