AzTrials
AzTrials

Refractory AnginaCOSIRA-IINCT05102019

Efficacy of the COronary SInus Reducer in Patients With Refractory Angina II

A study testing Arm 1: treatment with Shockwave Reducer and Arm 3 (unblinded, non-randomized): Single arm registry in people with Refractory Angina, run by Shockwave Medical, Inc. at 97 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Refractory Angina
What is being tested?
Arm 1: treatment with Shockwave Reducer and Arm 3 (unblinded, non-randomized): Single arm registry
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
380 participants
Where
97 sitesin 3 countries
Study dates
4 Jan 2022to Jan 2032
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject is older than 18 years of age
  • 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
  • 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
  • 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
  • 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
  • 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.
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  • 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.
  • Subject is willing and able to sign informed consent
  • 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

Who cannot join

  • 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
  • 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
  • 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
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  • 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)
  • 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)
  • NYHA Class III or IV heart failure (HF), decompensated HF or hospitalization due to HF during the 90 days prior to enrollment
  • Life threatening rhythm disorders or any rhythm disorders that would require future placement of an internal defibrillator and/or pacemaker
  • 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
  • Severe valvular heart disease (any valve)
  • Moderate or severe RV dysfunction by echocardiography
  • Pacemaker electrode/lead is present in the coronary sinus
  • A Class I indication is present for an implantable defibrillator or cardiac resynchronization therapy according to ACCF/AHA/HRS guidelines
  • Recent implantation of a new pacemaker or defibrillator lead with electrode in the right atrium within 90 days of enrollment
  • Chronic severe renal failure (estimated eGFR less than 30 mL/min/1.73m2 by the MDRD formula) or subjects on chronic dialysis
  • Known allergy to stainless steel or nickel
  • 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)
  • 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
  • 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)
  • 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.
  • 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
  • Comorbidities limiting life expectancy to less than one year
  • Subject is currently hospitalized for definite or suspected COVID-19
  • 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
  • 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:
  • Mean right atrial pressure greater than 15 mmHg assessed during the final screening procedure for eligibility assessment and potential randomization
  • Anomalous or abnormal CS anatomy (e.g., tortuosity, aberrant branch, persistent left superior vena cava [SVC]) as demonstrated by angiogram
  • 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):
  • 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
  • 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
  • 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)
  • 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
  • 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
  • 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
  • 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).
  • 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.

Trial locations and contacts

97 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

COSIRA-II Study Team contact

Fax: 1-888-887-8097

connect.cosira2@shockwavemedical.com

97 sites in 3 countries

United States72 sites, 67 recruiting

  • University of Michigan

    Ann Arbor, Michigan, 48109

    Allison Schley, 734-232-9051, schleya@med.umich.edu

    Brett Wanamaker, MD

    Recruiting

  • Emory Hospital

    Atlanta, Georgia, 30308

    Wei Xu, wei.xu@emory.edu

    William Nicholson

    Recruiting

  • Northside Hospital

    Atlanta, Georgia, 30342

    Withdrawn

  • Ascension Texas Cardiovascular

    Austin, Texas, 78705

    Richa Bajaj, richa.bajaj@ascension.org

    Mark Gajjar

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Devin Maximus, DMAXIMUS@mgh.harvard.edu

    Farouc Jaffer, MD

    Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02120

    Evan Devita, 617-732-7381, edevita@bwh.harvard.edu

    617-732-7381, tmunson@bwh.harvard.edu

    Recruiting

  • Ascension St. Vincent Heart Center

    Carmel, Indiana, 46920

    Patrice Powell, patrice.powell@ascension.org

    Bryce Lynn

    Recruiting

  • Novant Health

    Charlotte, North Carolina, 28204

    Elizabeth Marshall, Elizabeth.Marshall@novanthealth.org

    Parampreet Vidwan

    Recruiting

  • University of Virginia

    Charlottesville, Virginia, 22908

    Lynda Bryceland, 4349821058, lgs2m@uvahealth.org

    Rajan Patel

    Recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    Maeve Eskandari, maeve.eskandari@nm.org

    Dan Schimmel

    Recruiting

  • The Christ Hospital

    Cincinnati, Ohio, 45219

    Mikayla Tackett, RN, mikayla.tackett@thechristhospital.com

    Timothy Henry, MD

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Shawn McDaniel, MCDANIS4@ccf.org

    Jaikirshan Khatri, MD

    Recruiting

  • The Ohio State University

    Columbus, Ohio, 43210

    Annie Kellum, 614 366 8848, Annie.kellum@osumc.edu

    Scott Lilly, MD

    Recruiting

  • Henry Ford Hospital

    Detroit, Michigan, 48202

    Melanee Schimmel, 3139167614, mschimm2@hfhs.org

    Gerald Koenig

    Recruiting

  • Henry Ford St. Johns

    Detroit, Michigan, 48236

    Renee Bess, 3133434811, rbess1@hfhs.org

    Edouard Daher

    Recruiting

  • Medical City Fort Worth

    Fort Worth, Texas, 76104

    Bhagawathy Sarma, Bhagawathy.Sarma@HCAhealthcare.com

    Amir Malik, MD

    Recruiting

  • The Cardiac and Vascular Institute

    Gainesville, Florida, 32605

    Marti Roberson, 352-244-0208, Mroberson@tcavi.com

    Matheen Khuddus, MD

    Recruiting

  • Northeast Georgia

    Gainsville, Georgia, 30501

    Donna Patrick, 6789895001, Donna.Patrick@nghs.com

    Olga Toleva

    Recruiting

  • Corewell Health

    Grand Rapids, Michigan, 59403

    Ashley Grace Davies, 6163912205, AshleyGrace.Davies@corewellhealth.org

    Devraj Sukul

    Recruiting

  • Hackensack University

    Hackensack, New Jersey, 07601

    Jennifer Baxter, jennifer.baxter@hmhn.org

    Haroon Faraz

    Recruiting

  • Cardiovascular Institute of the South

    Houma, Louisiana, 70360

    Deanna Benoit, deanna.benoit@cardio.com

    Vinod Nair

    Recruiting

  • HCA Houston Healthcare Medical Center

    Houston, Texas, 77004

    Withdrawn

  • Houston Methodist

    Houston, Texas, 77030

    Padmaja Naik, pvnaik@houstonmethodist.org

    Alpesh Shah

    Recruiting

  • Texas Heart Institute

    Houston, Texas, 77030

    Sebrina Tello, sebrina.tello@bcm.edu

    Emerson Perin

    Recruiting

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77030

    Anna Menezes, anna.m.menezes@uth.tmc.edu

    Salman Arain, MD

    Recruiting

  • Jackson Heart Clinic

    Jackson, Mississippi, 39216

    Claire Hammack, 6019827850, chammack@jacksonheart.com

    William Crowder

    Recruiting

  • UF Health Jacksonville

    Jacksonville, Florida, 32209

    Kailyn Herndon, Kennedy.healy@jax.ufl.edu

    Daniel Soffer

    Recruiting

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

    Kartik Munshi, 9139456445, kmunshi@kumc.edu

    Prasad Gunasekaran

    Recruiting

  • Saint Luke's Hospital

    Kansas City, Missouri, 64111

    Lisa Lacy, 816-932-7528, lisa.lacy@bjc.org

    Anthony Hart, MD

    Recruiting

  • South Denver Cardiology Associates

    Littleton, Colorado, 80120

    Kathy Siegel, ksiegel@southdenver.com

    Lee McDonald

    Recruiting

  • Long Beach VA Medical Center

    Long Beach, California, 90822

    Withdrawn

  • USC Keck School of Medicine

    Los Angeles, California, 90033

    Melissa Ramos, melissa.ramos@med.usc.edu

    Jubin Joseph

    Recruiting

  • Cedars-Sinai

    Los Angeles, California, 90048

    Kirin Bhatia, Kirin.Bhatia@csmns.org

    Suhail Dohad, MD

    Recruiting

  • University of Louisville

    Louisville, Kentucky, 40202

    Terry Blanton, RN, (502) 587-4381, mary.blanton@louisville.edu

    Yuvraj Chowdhury

    Recruiting

  • University of Wisconsin

    Madison, Wisconsin, 53792

    Anna Lonergan, alamonica@medicine.wisc.edu

    Amish Raval

    Recruiting

  • Wellstar Kennestone Hospital

    Marietta, Georgia, 30062

    Jessica Certain, jessica.certain@wellstar.org

    Salvatore Mannino

    Recruiting

  • Mount Sinai Miami

    Miami Beach, Florida, 33140

    Ana Mon, ana.mon@msmc.com

    Nirat Beohar

    Recruiting

  • Advocate Aurora Research Institute

    Milwaukee, Wisconsin, 53215

    Sara Klien

    Joaquin Solis

    Recruiting

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407

    Lydia Zenner, lydia.zenner@allina.com

    Jay Traverse

    Recruiting

  • Community Hospital - Munster

    Munster, Indiana, 46321

    Magdelena Borzecka, 2194007325

    Dean Ferrera

    Recruiting

  • NCH Healthcare - Naples

    Naples, Florida, 34102

    Kathy Byrd, kathy.byrd@nchmd.org

    Frank Adam

    Recruiting

  • TriStar Centennial Medical Center

    Nashville, Tennessee, 37203

    Michael Brown, 615-417-1035, Michael.Brown@hcahealthcare.com

    Brian Jefferson, MD

    Recruiting

  • Vanderbilt Heart

    Nashville, Tennessee, 37232

    Sherron Crook, sherron.c.crook@vumc.org

    Nadia Sutton, MD

    Recruiting

  • Yale University

    New Haven, Connecticut, 06519

    Scott Ardito, scott.ardito@yale.edu

    Samit Shah, MD

    Recruiting

  • Mount Sinai Medical Center

    New York, New York, 10003

    Nimisha Baruah, 212-241-6938, Nimisha.baruah@mounsinai.org

    Samin Sharma, MD

    Recruiting

  • NYU Langone

    New York, New York, 10010

    Manuela Plazas Montana, 2407437096, Manuela.PlazasMontana@nyulangone.org

    Amanda Joa, 347-515-1154, Amanda.Joa@nyulangone.org

    Recruiting

  • Weill Cornell Medicine

    New York, New York, 10021

    Dolores Reynolds, 2127464617, dtr2001@med.cornell.edu

    Jai Khatri

    Recruiting

  • Columbia University Medical Center/NYPH

    New York, New York, 10032

    Christian Viaje, 2123421820, cv2555@cumc.columbia.edu

    Ajay Kirtane, MD

    Recruiting

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

    Ashley McQuarter, axmcquar@sentara.com

    Paul Lavigne, MD

    Recruiting

  • Ascension Sacred Heart

    Pensacola, Florida, 32504

    Jessica Flores, jessica.flores8@ascension.org

    Rohit Amin

    Recruiting

  • Mayo Clinic

    Phoenix, Arizona, 85054

    Monica McCarty, 480-574-1784, mccarty.monica@mayo.edu

    David Fortuin, MD

    Recruiting

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

    Tracy Spirk, 4123594025, Tracy.SPIRK@ahn.org

    Mithun Chakravarthy

    Recruiting

  • The Heart Hospital Baylor Plano

    Plano, Texas, 75093

    Andres Santoyo, Andres.Santoyo@BSWHealth.org

    Srini Potluri

    Recruiting

  • Providence Heart Institute

    Portland, Oregon, 97225

    Sheryl Ames, 503-216-2170, Sheryl.Ames@providence.org

    Jason Wollmuth, MD

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55905

    Diana Albers, 507-284-2511, Albers.Diana2@mayo.edu

    Abhiram Prasad, MD

    Recruiting

  • St. Francis Hospital

    Roslyn, New York, 11576

    Marion Cyriac, RN, Marion.Cyriac@chsli.org

    Evan Shlofmitz, MD

    Recruiting

  • Methodist Hospital of San Antonio

    San Antonio, Texas, 78229

    Susana Mondaca, Susana.MondacaBolanos@hcahealthcare.com

    Abelardo Martinez-Rumayor, MD

    Recruiting

  • UCSD

    San Diego, California, 92037

    Maylene Alegre, malegre@health.ucsd.edu

    Ehtisham Mahmud, MD

    Recruiting

  • Kaiser Permanente San Francisco

    San Francisco, California, 94115

    Jess Codispoti, Jess.X.Codispoti@kp.org

    Gopi Manthripragada

    Recruiting

  • UCSF

    San Francisco, California, 94117

    Kaye Reambonanza, 4155146147, Kaye.Reambonanza@ucsf.edu

    Yousif Ahmad

    Recruiting

  • HonorHealth Research Institute

    Scottsdale, Arizona, 85258

    Ethan Ashley, eashley@honorhealth.com

    Taral Patel, MD

    Recruiting

  • Henry Ford Providence

    Southfield, Michigan, 48075

    Yulia Abidov, 2488495328, yulia.abidov@ascension.org

    Shukri David, MD

    Recruiting

  • Southern Illinois University

    Springfield, Illinois, 62781

    Madison Hollishead, 217-545-7387, hollinshead64@siumed.edu

    Abdul Moiz Hafiz

    Recruiting

  • Baystate Medical Center

    Springfield, Massachusetts, 01199

    Christine Callahan, 4137949076, christine.callahan@baystatehealth.org

    Amir Lotfi, MD

    Recruiting

  • Tallahassee Research Institute

    Tallahassee, Florida, 32308

    Wendie Najdowski, 850-431-5024, wendie.najdowski@tmh.org

    Thomas Noel, MD

    Recruiting

  • Tampa General - USF Cardiology

    Tampa, Florida, 33606

    Mia Eifrid, miaeifrid@usf.edu

    Fadi Matar

    Recruiting

  • Los Robles Hospital and Medical Center

    Thousand Oaks, California, 91360

    Mane Arabyan, (805) 796-3746, Mane.Arabyan@HCAHealthcare.com

    Saibal Kar, MD

    Recruiting

  • University of Arizona Sarver Heart Center

    Tucson, Arizona, 85724

    Lizzette Cruz, RN, (520) 626-2471, marquez@shc.arizona.edu

    Michel Corban, MD

    Recruiting

  • Ascension St. John

    Tulsa, Oklahoma, 74104

    Diamond Sims, diamond.sims@ascension.org

    Thomas Kalapura

    Recruiting

  • Cardiology Associates of North Mississippi

    Tupelo, Mississippi, 38801

    Withdrawn

  • MedStar Cardiovascular Research Network

    Washington D.C., District of Columbia, 20010

    Michelle Singh, Michelle.Singh@medstar.net

    Hayder Hashim, MD

    Recruiting

  • Cardiovascular Research Institute of Kansas

    Wichita, Kansas, 67226

    Withdrawn

Other trials in United States

United Kingdom20 sites, 20 recruiting

  • Essex Cardiothoracic Centre

    Basildon, SS16 5NL

    Emily Redman, emily.redman@nhs.net

    Thomas Keeble, MD

    Recruiting

  • Queen Elizabeth Hospital Birmingham

    Birmingham, B15 2GW

    Kahmeelah Dowling, kahmeelah.dowling@uhb.nhs.uk

    Alex Zaphiriou, MD

    Recruiting

  • Bristol Heart Institute

    Bristol, BS2 8HW

    Laura Gallego, laura.gallego@uhbw.nhs.uk

    Ioannis Felekos, MD

    Recruiting

  • Royal Papworth Hospital

    Cambridge, |CB2 0AY

    Rebecca Hussey, rebecca.hussey4@nhs.net

    Stephen Hoole, MD

    Recruiting

  • Dorset County Hospital NHS Foundation Trust

    Dorchester, DT1 2JY

    Jenny Rees, jenny.rees@dchft.nhs.uk

    Fraser Witherow, MD

    Recruiting

  • Kettering General Hospital

    Kettering, NN16 8UZ

    Swarga George, swarga.george1@nhs.net

    Prashanth Raju, MD

    Recruiting

  • Glenfield Hospital, Leicester

    Leicester, LE3 9QP

    Jude Fisher, jude.a.fisher@uhl-tr.nhs.uk

    Bhavik Modi, MD

    Recruiting

  • Liverpool Heart and Chest Hospital NHS Foundation Trust

    Liverpool, L14 3PE

    Maureen Baker, maureen.baker@lhch.nhs.uk

    Joel Giblett, MD

    Recruiting

  • Barts Health Centre

    London, E1 1FR

    Pedro Pinto, p.pinto1@nhs.net

    Anthony Mathur, MD

    Recruiting

  • Royal Free Hospital

    London, NW3 2QG

    Nina Arnold, Nina.arnold@nhs.net

    Gerry Coghlan, MD

    Recruiting

  • St. Thomas Hospital

    London, SE1 7EH

    Sophie Arnold, sophie.arnold5@nhs.net

    Tiffany Patterson, MD

    Recruiting

  • King's College Hospital

    London, SE5 9RS

    Michelle Andrews, michelle.andrews1@nhs.net

    Jonathan Byrne, MD

    Recruiting

  • St. Georges University Hospital

    London, SW17 0QT

    Vennessa Sookhoo, vsookhoo@sgul.ac.uk

    James Spratt, MD

    Recruiting

  • Royal Brompton Hospital

    London, SW3 6NP

    Marcus Farias, m.farias1@rbht.nhs.uk

    Ranil De Silva, MD

    Recruiting

  • Imperial College Healthcare NHS Trust

    London, W12 0HS

    Maricris Tuason, maricris.tuason@nhs.net

    Rasha Al-Lamee, MD

    Recruiting

  • Freeman Hospital

    Newcastle upon Tyne, NE7 7DN

    Laura Gordon, l.gordon7@nhs.net

    Bilal Bawamia, MD

    Recruiting

  • Nottingham University Hospital

    Nottingham, NG5

    Jane Quinn, jane.quinn7@nhs.net

    Andrew Vanezis, MD

    Recruiting

  • Oxford University Hospital

    Oxford, OX3 9DU

    Anisha Shaji, anisha.shaji@ouh.nhs.uk

    Giovanni De Maria, MD

    Recruiting

  • Royal Bournemouth Hospital

    Poole, BH15 2JB

    Tanith Changuion, t.changuion@nhs.net

    Peter O'Kane, MD

    Recruiting

  • Musgrove Park Hospital

    Taunton, TA1 5DA

    Helen Mills, cvresearchteam@somersetft.nhs.uk

    Mohammad Sahebjalal, MD

    Recruiting

Other trials in United Kingdom

Canada5 sites, 5 recruiting

  • CHUM

    Montreal, Quebec, H2X 0C1

    Adriana Carbonaro, adriana.carbonaro.chum@ssss.gouv.qc.ca

    Marc Jolicoeur, MD

    Recruiting

  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1y4W7

    Hannah Feagan, hfeagan@ottawaheart.ca

    Mariano Labinaz

    Recruiting

  • IUCPQ-Ulaval

    Québec, Quebec, G1V4G5

    Michele Jadin, 418-656-8711 ext. 3007, Michele.Jadin@criucpq.ulaval.ca

    Jean-Michael Paradis, MD

    Recruiting

  • Toronto General Hospital (UHN)

    Toronto, Ontario, M5G 2C4

    Anna Thran, Anna.Tran3@uhn.ca

    Vladimir Dzavik

    Recruiting

  • Vancouver General Hospital

    Vancouver, British Columbia, V521M9

    Naomi Uchida, naomi.uchida@ubc.ca

    David Wood

    Recruiting

Other trials in Canada

About this study

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.

Read the detailed description

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

Being tested
Arm 1: treatment with Shockwave Reducer, Arm 2 (control): Implantation procedure with no device implanted, Arm 3 (unblinded, non-randomized): Single arm registry
Medical subject headings
Angina Pectoris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Arm 1: treatment with Shockwave ReducerDevice

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

  • Arm 2 (control): Implantation procedure with no device implantedOther

    No device is implanted

  • Arm 3 (unblinded, non-randomized): Single arm registryDevice

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

Study groups in NCT05102019
Study groupRoleWhat they receive
Arm 1 (treatment arm):Implantation of the Reducer deviceExperimentalNot described
Receives: Device: Arm 1: treatment with Shockwave Reducer
Arm 2 (sham-control arm): Control (no device implantation)Sham comparatorNot described
Receives: Other: Arm 2 (control): Implantation procedure with no device implanted
Arm 3 (unblinded, non-randomized): Single Arm RegistryOtherNot described
Receives: Device: Arm 3 (unblinded, non-randomized): Single arm registry

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Co-Primary Effectiveness Endpoints

    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.

    Measured: 6 months

  2. Primary Safety Endpoints

    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.

    Measured: 6 months

Secondary outcomes (2)

  1. Canadian Cardiovascular Society (CCS) Angina Score

    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).

    Measured: 6 months

  2. Canadian Cardiovascular Society (CCS) Angina Score

    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).

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2021
  2. Study start4 Jan 2022
  3. Primary completionJul 2027 (estimated)
  4. Study completionJan 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
380 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05102019
Sponsor's protocol ID
022-REDUCLN-002
Acronym
COSIRA-II
Status last verified
Sep 2026
First submitted
8 Oct 2021
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Verheye S, Jolicoeur EM, Behan MW, Pettersson T, Sainsbury P, Hill J, Vrolix M, Agostoni P, Engstrom T, Labinaz M, de Silva R, Schwartz M, Meyten N, Uren NG, Doucet S, Tanguay JF, Lindsay S, Henry TD, White CJ, Edelman ER, Banai S. Efficacy of a device to narrow the coronary sinus in refractory angina. N Engl J Med. 2015 Feb 5;372(6):519-27. doi: 10.1056/NEJMoa1402556.

    PubMed 25651246

  • Bourdillon MT, Johnson NP, Anderson HVS. Post-PCI coronary physiology: clinical outcomes and can we optimize? Cardiovasc Revasc Med. 2025 Apr;73:91-97. doi: 10.1016/j.carrev.2024.11.013. Epub 2024 Dec 5.

    PubMed 39668004

  • Bober RM, Johnson NP. How might coronary sinus reducer treatment change myocardial perfusion? J Nucl Cardiol. 2024 Mar;33:101828. doi: 10.1016/j.nuclcard.2024.101828. Epub 2024 Feb 21. No abstract available.

    PubMed 38395338

Questions about this trial

What is this clinical trial studying?

A study testing Arm 1: treatment with Shockwave Reducer and Arm 3 (unblinded, non-randomized): Single arm registry in people with Refractory Angina, run by Shockwave Medical, Inc. at 97 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 54 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 97 sites in United States, United Kingdom, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact COSIRA-II Study Team (Fax: 1-888-887-8097, connect.cosira2@shockwavemedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Co-Primary Effectiveness Endpoints (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05102019, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.

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