Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Effekten av koronar sinusreduceraren hos patienter med refraktär angina II (COSIRA-II)

25 september 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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

Studietyp

Interventionell

Inskrivning (Beräknad)

380

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Arm 1 (behandlingsarm): Implantation av reduktionsanordningen
Enhet: Arm 1: treatment with Shockwave Reducer

Shockwave reducer is an implantable device being evaluated for the alleviation of refractory angina symptoms
Sham Comparator: Arm 2 (skenkontrollarm): Kontroll (ingen enhetsimplantation)
Övrig: Arm 2 (control): Implantation procedure with no device implanted

No device is implanted
Övrig: Arm 3 (oblindad, icke-randomiserad): Single Arm Registry
Enhet: Arm 3 (unblinded, non-randomized): Single arm registry

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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Co-Primary Effectiveness Endpoints
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Canadian Cardiovascular Society (CCS) Angina Score
Tidsram: 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
Tidsram: 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

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Canadian Cardiovascular Society (CCS) Angina Score
Tidsram: 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
Tidsram: 6 and 12 months

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

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

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

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

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Shockwave Medical, Inc.

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

4 januari 2022

Primärt slutförande (Beräknad)

1 juli 2027

Avslutad studie (Beräknad)

1 januari 2032

Studieregistreringsdatum

Först inskickad

8 oktober 2021

Först inskickad som uppfyllde QC-kriterierna

21 oktober 2021

Första postat (Faktisk)

1 november 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

30 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

25 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 022-REDUCLN-002

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Ja

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera