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Werkzaamheid van de COronaire Sinus-reducer bij patiënten met refractaire angina II (COSIRA-II)

25 september 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Studietype

Ingrijpend

Inschrijving (Geschat)

380

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Arm 1 (behandelingsarm): Implantatie van het Reducer-apparaat
Apparaat: Arm 1: treatment with Shockwave Reducer

Shockwave reducer is an implantable device being evaluated for the alleviation of refractory angina symptoms
Sham-vergelijker: Arm 2 (schijncontrole-arm): controle (geen apparaatimplantatie)
Ander: Arm 2 (control): Implantation procedure with no device implanted

No device is implanted
Ander: Arm 3 (niet-geblindeerd, niet-gerandomiseerd): register met één arm
Apparaat: Arm 3 (unblinded, non-randomized): Single arm registry

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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Co-Primary Effectiveness Endpoints
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Canadian Cardiovascular Society (CCS) Angina Score
Tijdsspanne: 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
Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Canadian Cardiovascular Society (CCS) Angina Score
Tijdsspanne: 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
Tijdsspanne: 6 and 12 months

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

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

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

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

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Shockwave Medical, Inc.

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

4 januari 2022

Primaire voltooiing (Geschat)

1 juli 2027

Studie voltooiing (Geschat)

1 januari 2032

Studieregistratiedata

Eerst ingediend

8 oktober 2021

Eerst ingediend dat voldeed aan de QC-criteria

21 oktober 2021

Eerst geplaatst (Werkelijk)

1 november 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

30 september 2026

Laatste update ingediend die voldeed aan QC-criteria

25 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 022-REDUCLN-002

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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