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Effekten af ​​COronary Sinus Reducer hos patienter med refraktær angina II (COSIRA-II)

25. september 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

380

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Arm 1 (behandlingsarm): Implantation af reduktionsanordningen
Enhed: Arm 1: treatment with Shockwave Reducer

Shockwave reducer is an implantable device being evaluated for the alleviation of refractory angina symptoms
Sham-komparator: Arm 2 (sham-kontrolarm): Kontrol (ingen enhedsimplantation)
Andet: Arm 2 (control): Implantation procedure with no device implanted

No device is implanted
Andet: Arm 3 (ublindet, ikke-randomiseret): Single Arm Registry
Enhed: Arm 3 (unblinded, non-randomized): Single arm registry

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Co-Primary Effectiveness Endpoints
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Canadian Cardiovascular Society (CCS) Angina Score
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Canadian Cardiovascular Society (CCS) Angina Score
Tidsramme: 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
Tidsramme: 6 and 12 months

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

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

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

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

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Shockwave Medical, Inc.

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

4. januar 2022

Primær færdiggørelse (Anslået)

1. juli 2027

Studieafslutning (Anslået)

1. januar 2032

Datoer for studieregistrering

Først indsendt

8. oktober 2021

Først indsendt, der opfyldte QC-kriterier

21. oktober 2021

Først opslået (Faktiske)

1. november 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 022-REDUCLN-002

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

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