Efficacy of the COronary SInus Reducer in Patients With Refractory Angina II
NCT ID: NCT05102019
Last Updated: 2026-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
380 participants
INTERVENTIONAL
2022-01-04
2032-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm 1 (treatment arm):Implantation of the Reducer device
Arm 1: treatment with Shockwave Reducer
Neovasc reducer is an implantable device being evaluated for the alleviation of refractory angina symptoms
Arm 2 (sham-control arm): Control (no device implantation)
Arm 2 (control): Implantation procedure with no device implanted
No device is implanted
Arm 3 (unblinded, non-randomized): Single Arm Registry
Arm 3 (unblinded, non-randomized): Single arm registry
Shockwave Reducer is an implantable device being evaluated for the alleviation of refractory angina symptoms
Interventions
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Arm 1: treatment with Shockwave Reducer
Neovasc reducer is an implantable device being evaluated for the alleviation of refractory angina symptoms
Arm 2 (control): Implantation procedure with no device implanted
No device is implanted
Arm 3 (unblinded, non-randomized): Single arm registry
Shockwave Reducer is an implantable device being evaluated for the alleviation of refractory angina symptoms
Eligibility Criteria
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Inclusion Criteria
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 and while the patient is maintained on their stable regimen of maximally tolerated doses of anti-anginal medications 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. 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
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
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
Non-obstructive coronary artery disease subjects (ANOCA)
1. Abnormal Coronary Flow Reserve (CFR): subjects must have either abnormal PET CFR (\< 2.0) 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
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).
Exclusion Criteria
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
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
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
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
18 Years
ALL
No
Sponsors
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Shockwave Medical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Timothy D Henry, MD
Role: PRINCIPAL_INVESTIGATOR
The Christ Hospital Health Network
Gregg W Stone, MD
Role: PRINCIPAL_INVESTIGATOR
Mt. Sinai Heart Health
Locations
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Mayo Clinic
Phoenix, Arizona, United States
HonorHealth Research Institute
Scottsdale, Arizona, United States
University of Arizona Sarver Heart Center
Tucson, Arizona, United States
Long Beach VA Medical Center
Long Beach, California, United States
Cedars-Sinai
Los Angeles, California, United States
UCSD
San Diego, California, United States
Kaiser Permanente San Francisco
San Francisco, California, United States
UCSF
San Francisco, California, United States
Los Robles Hospital and Medical Center
Thousand Oaks, California, United States
South Denver Cardiology Associates
Littleton, Colorado, United States
Yale University
New Haven, Connecticut, United States
MedStar Cardiovascular Research Network
Washington D.C., District of Columbia, United States
The Cardiac and Vascular Institute
Gainesville, Florida, United States
UF Health Jacksonville
Jacksonville, Florida, United States
Mount Sinai Miami
Miami Beach, Florida, United States
NCH Healthcare - Naples
Naples, Florida, United States
Ascension Sacred Heart
Pensacola, Florida, United States
Tallahassee Research Institute
Tallahassee, Florida, United States
Tampa General - USF Cardiology
Tampa, Florida, United States
Emory Hospital
Atlanta, Georgia, United States
Northside Hospital
Atlanta, Georgia, United States
Northeast Georgia
Gainesville, Georgia, United States
Wellstar Kennestone Hospital
Marietta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Southern Illinois University
Springfield, Illinois, United States
Ascension St. Vincent Heart Center
Carmel, Indiana, United States
Community Hospital - Munster
Munster, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Cardiovascular Research Institute of Kansas
Wichita, Kansas, United States
Cardiovascular Institute of the South
Houma, Louisiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Baystate Medical Center
Springfield, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford St. Johns
Detroit, Michigan, United States
Corewell Health
Grand Rapids, Michigan, United States
Henry Ford Providence
Southfield, Michigan, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Jackson Heart Clinic
Jackson, Mississippi, United States
Cardiology Associates of North Mississippi
Tupelo, Mississippi, United States
Saint Luke's Hospital
Kansas City, Missouri, United States
Hackensack University
Hackensack, New Jersey, United States
Mount Sinai Medical Center
New York, New York, United States
NYU Langone
New York, New York, United States
Weill Cornell Medicine
New York, New York, United States
Columbia University Medical Center/NYPH
New York, New York, United States
St. Francis Hospital
Roslyn, New York, United States
Novant Health
Charlotte, North Carolina, United States
The Christ Hospital
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Ascension St. John
Tulsa, Oklahoma, United States
Providence Heart Institute
Portland, Oregon, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
TriStar Centennial Medical Center
Nashville, Tennessee, United States
Vanderbilt Heart
Nashville, Tennessee, United States
Ascension Texas Cardiovascular
Austin, Texas, United States
Medical City Fort Worth
Fort Worth, Texas, United States
HCA Houston Healthcare Medical Center
Houston, Texas, United States
Houston Methodist
Houston, Texas, United States
Texas Heart Institute
Houston, Texas, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
The Heart Hospital Baylor Plano
Plano, Texas, United States
Methodist Hospital of San Antonio
San Antonio, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
University of Wisconsin
Madison, Wisconsin, United States
Advocate Aurora Research Institute
Milwaukee, Wisconsin, United States
Vancouver General Hospital
Vancouver, British Columbia, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Toronto General Hospital (UHN)
Toronto, Ontario, Canada
CHUM
Montreal, Quebec, Canada
IUCPQ-Ulaval
Québec, Quebec, Canada
Essex Cardiothoracic Centre
Basildon, , United Kingdom
Queen Elizabeth Hospital Birmingham
Birmingham, , United Kingdom
Bristol Heart Institute
Bristol, , United Kingdom
Dorset County Hospital NHS Foundation Trust
Dorchester, , United Kingdom
Kettering General Hospital
Kettering, , United Kingdom
Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool, , United Kingdom
Barts Health Centre
London, , United Kingdom
Royal Free Hospital
London, , United Kingdom
St. Thomas Hospital
London, , United Kingdom
King's College Hospital
London, , United Kingdom
Royal Brompton Hospital
London, , United Kingdom
Imperial College Healthcare NHS Trust
London, , United Kingdom
Freeman Hospital
Newcastle upon Tyne, , United Kingdom
Nottingham University Hospital
Nottingham, , United Kingdom
Oxford University Hospital
Oxford, , United Kingdom
Royal Bournemouth Hospital
Poole, , United Kingdom
Musgrove Park Hospital
Taunton, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Magdelena Borzecka
Role: primary
Jennifer Parenti
Role: primary
Sara Klien
Role: primary
References
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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.
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.
Other Identifiers
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022-REDUCLN-002
Identifier Type: -
Identifier Source: org_study_id
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