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难治性心绞痛 II 型冠状窦减压器的疗效 (COSIRA-II)

2026年9月25日 更新者：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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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

研究类型

介入性

注册 (估计的)

380

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：第 1 臂（治疗臂）：植入 Reducer 装置
设备：Arm 1: treatment with Shockwave Reducer

Shockwave reducer is an implantable device being evaluated for the alleviation of refractory angina symptoms
假比较器：手臂 2（假控制臂）：控制（无设备植入）
其他：Arm 2 (control): Implantation procedure with no device implanted

No device is implanted
其他：第 3 组（非盲法、非随机化）：单臂登记
设备：Arm 3 (unblinded, non-randomized): Single arm registry

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

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Co-Primary Effectiveness Endpoints
大体时间：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
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Canadian Cardiovascular Society (CCS) Angina Score
大体时间：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
大体时间：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

其他结果措施

结果测量
措施说明
大体时间
Canadian Cardiovascular Society (CCS) Angina Score
大体时间：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
大体时间：6 and 12 months

Angina frequency and burden compared to baseline
6 and 12 months
Activity
大体时间：6 and 12 months

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

Change in ETT parameters compared to baseline
6 and 12 months
Exercise Tolerance Testing
大体时间：12 months

Change in total exercise duration compared to baseline
12 months
Doctor Visits
大体时间：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
大体时间：6 and 12 months

Total exercise duration
6 and 12 months
Seattle Angina Questionnaire (SAQ) Score
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Shockwave Medical, Inc.

调查人员

  • 首席研究员：Timothy D Henry, MD、The Christ Hospital Health Network
  • 首席研究员：Gregg W Stone, MD、Mt. Sinai Heart Health

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2022年1月4日

初级完成 (估计的)

2027年7月1日

研究完成 (估计的)

2032年1月1日

研究注册日期

首次提交

2021年10月8日

首先提交符合 QC 标准的

2021年10月21日

首次发布 (实际的)

2021年11月1日

研究记录更新

最后更新发布 (实际的)

2026年9月30日

上次提交的符合 QC 标准的更新

2026年9月25日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 022-REDUCLN-002

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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