Efficacy of a device to narrow the coronary sinus in refractory angina.
Stefan Verheye, E Marc Jolicœur, Miles W Behan...
https://pubmed.ncbi.nlm.nih.gov/25651246Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID05102019
Efficacy of the COronary SInus Reducer in Patients With Refractory Angina II
Led by Shockwave Medical, Inc. · Updated on 2026-04-22
380
Participants Needed
95
Research Sites
235 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the Shockwave Reducer device in treating patients with refractory angina pectoris who have persistent symptoms despite maximum medical therapy and cannot undergo revascularization. The study focuses on those with reversible myocardial ischemia in the left coronary artery and includes a non-randomized registry for certain patients with issues in the right coronary artery, no obstructive coronary disease, or mobility limitations. This is a multicenter, randomized, double-blinded, sham-controlled clinical trial. Participants are randomly assigned in a 1:1 ratio to either receive the Shockwave Reducer implant or undergo a sham implantation procedure without the device. A third unblinded, non-randomized registry arm includes patients meeting specific criteria with reversible ischemia but not eligible for randomization. The study includes follow-up over six months to assess safety and effectiveness outcomes, including angina severity measured by the Canadian Cardiovascular Society (CCS) Angina Score. During the trial, participants will undergo evaluations to confirm eligibility and monitor heart function, ischemia, and symptoms using tests such as stress echocardiography, nuclear studies, or exercise tolerance tests. Researchers will review co-primary effectiveness and safety endpoints at six months. Patients are expected to maintain stable medication regimens and comply with follow-up visits to help assess the device's impact on angina symptoms and heart performance.
CONDITIONS
Brief Title
Efficacy of the COronary SInus Reducer in Patients With Refractory Angina II
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Symptomatic coronary artery disease with at least 90 days of refractory angina classified as CCS Grade III or IV despite maximum guideline-directed medical therapy
- Stable use of at least three of four approved anti-anginal medication classes for at least 30 days prior to enrollment
- No suitable options for coronary artery bypass grafting or percutaneous coronary intervention as confirmed by local heart team
- Evidence of reversible ischemia in the left coronary artery within 12 months prior to enrollment
- Functional limitation with exercise tolerance test lasting between 2 and 10 minutes
- Left ventricular ejection fraction of 30% or greater within 12 months prior to enrollment
- Willing and able to provide informed consent
- Willing to comply with follow-up evaluations
- Coronary angiography within 12 months showing obstructive coronary artery disease in the left coronary artery not suitable for revascularization
You will not qualify if you...
- Acute coronary syndrome with positive troponin or CKMB within 30 days prior to enrollment
- Successful coronary artery bypass grafting or percutaneous coronary intervention within 6 months prior to enrollment
- Unsuccessful percutaneous coronary intervention within 30 days prior to enrollment
- Predominant symptom is dyspnea rather than angina
- Untreated hyperthyroidism, anemia with hemoglobin less than 10 g/dL, uncontrolled hypertension, rapid atrial fibrillation, severe aortic stenosis, hypertrophic cardiomyopathy with obstruction, or coronary artery vasospasm
- NYHA Class III or IV heart failure or recent hospitalization for heart failure
- Life-threatening or requiring device rhythm disorders
- Severe chronic obstructive pulmonary disease or need for oxygen or steroids at home
- Severe valvular heart disease or moderate to severe right ventricular dysfunction
- Presence of pacemaker electrode in coronary sinus
- Indication for implantable defibrillator or cardiac resynchronization therapy
- Recent implantation of pacemaker or defibrillator lead in right atrium within 90 days
- Severe renal failure or dialysis
- Allergy to stainless steel or nickel
- Conditions interfering with trial compliance such as active substance abuse, dementia, or planned MRI within 8 weeks
- Enrollment in another investigational trial that may interfere
- Pregnancy or planning pregnancy within 12 months
- Vulnerable populations unable to give informed consent
- Inability to tolerate required antiplatelet therapy
- Life expectancy less than one year
- Current or recent COVID-19 infection with symptoms or positive test within specified timeframes
- Coronary anatomy suitable for revascularization with low risk and good expected symptom relief
- Mean right atrial pressure above 15 mmHg
- Abnormal coronary sinus anatomy or unsuitable size for implant
- Other criteria defined for single-arm registry participants
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Single procedure with immediate post-procedure observation
Participants undergo implantation of the Shockwave Reducer device or a sham procedure without device implantation.
1 visit (in-person)
Post-operative Follow-up
Duration - 6 months
Participants are followed to assess safety and effectiveness of the device over time.
Multiple follow-up visits during 6 months
Trial Site Locations
Total: 95 locations
1
Mayo Clinic
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
HonorHealth Research Institute
Scottsdale, Arizona, United States, 85258
Actively Recruiting
3
University of Arizona Sarver Heart Center
Tucson, Arizona, United States, 85724
Actively Recruiting
4
Long Beach VA Medical Center
Long Beach, California, United States, 90822
Withdrawn
5
Cedars-Sinai
Los Angeles, California, United States, 90048
Actively Recruiting
6
UCSD
San Diego, California, United States, 92037
Actively Recruiting
7
Kaiser Permanente San Francisco
San Francisco, California, United States, 94115
Actively Recruiting
8
UCSF
San Francisco, California, United States, 94117
Actively Recruiting
9
Los Robles Hospital and Medical Center
Thousand Oaks, California, United States, 91360
Actively Recruiting
10
South Denver Cardiology Associates
Littleton, Colorado, United States, 80120
Actively Recruiting
11
Yale University
New Haven, Connecticut, United States, 06519
Actively Recruiting
12
MedStar Cardiovascular Research Network
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
13
The Cardiac and Vascular Institute
Gainesville, Florida, United States, 32605
Actively Recruiting
14
UF Health Jacksonville
Jacksonville, Florida, United States, 32209
Actively Recruiting
15
Mount Sinai Miami
Miami Beach, Florida, United States, 33140
Actively Recruiting
16
NCH Healthcare - Naples
Naples, Florida, United States, 34102
Actively Recruiting
17
Ascension Sacred Heart
Pensacola, Florida, United States, 32504
Actively Recruiting
18
Tallahassee Research Institute
Tallahassee, Florida, United States, 32308
Actively Recruiting
19
Tampa General - USF Cardiology
Tampa, Florida, United States, 33606
Actively Recruiting
20
Emory Hospital
Atlanta, Georgia, United States, 30308
Actively Recruiting
21
Northside Hospital
Atlanta, Georgia, United States, 30342
Withdrawn
22
Northeast Georgia
Gainsville, Georgia, United States, 30501
Actively Recruiting
23
Wellstar Kennestone Hospital
Marietta, Georgia, United States, 30062
Actively Recruiting
24
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
25
Southern Illinois University
Springfield, Illinois, United States, 62781
Actively Recruiting
26
Ascension St. Vincent Heart Center
Carmel, Indiana, United States, 46920
Actively Recruiting
27
Community Hospital - Munster
Munster, Indiana, United States, 46321
Actively Recruiting
28
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
29
Cardiovascular Research Institute of Kansas
Wichita, Kansas, United States, 67226
Withdrawn
30
Cardiovascular Institute of the South
Houma, Louisiana, United States, 70360
Actively Recruiting
31
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
32
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02120
Actively Recruiting
33
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
Actively Recruiting
34
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
35
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
36
Henry Ford St. Johns
Detroit, Michigan, United States, 48236
Actively Recruiting
37
Corewell Health
Grand Rapids, Michigan, United States, 59403
Actively Recruiting
38
Henry Ford Providence
Southfield, Michigan, United States, 48075
Actively Recruiting
39
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
40
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
41
Jackson Heart Clinic
Jackson, Mississippi, United States, 39216
Actively Recruiting
42
Cardiology Associates of North Mississippi
Tupelo, Mississippi, United States, 38801
Withdrawn
43
Saint Luke's Hospital
Kansas City, Missouri, United States, 64111
Actively Recruiting
44
Hackensack University
Hackensack, New Jersey, United States, 07601
Actively Recruiting
45
Mount Sinai Medical Center
New York, New York, United States, 10003
Actively Recruiting
46
NYU Langone
New York, New York, United States, 10010
Actively Recruiting
47
Weill Cornell Medicine
New York, New York, United States, 10021
Actively Recruiting
48
Columbia University Medical Center/NYPH
New York, New York, United States, 10032
Actively Recruiting
49
St. Francis Hospital
Roslyn, New York, United States, 11576
Actively Recruiting
50
Novant Health
Charlotte, North Carolina, United States, 28204
Actively Recruiting
51
The Christ Hospital
Cincinnati, Ohio, United States, 45219
Actively Recruiting
52
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
53
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
54
Ascension St. John
Tulsa, Oklahoma, United States, 74104
Actively Recruiting
55
Providence Heart Institute
Portland, Oregon, United States, 97225
Actively Recruiting
56
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
57
TriStar Centennial Medical Center
Nashville, Tennessee, United States, 37203
Actively Recruiting
58
Vanderbilt Heart
Nashville, Tennessee, United States, 37232
Actively Recruiting
59
Ascension Texas Cardiovascular
Austin, Texas, United States, 78705
Actively Recruiting
60
Medical City Fort Worth
Fort Worth, Texas, United States, 76104
Actively Recruiting
61
HCA Houston Healthcare Medical Center
Houston, Texas, United States, 77004
Withdrawn
62
Houston Methodist
Houston, Texas, United States, 77030
Actively Recruiting
63
Texas Heart Institute
Houston, Texas, United States, 77030
Actively Recruiting
64
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
65
The Heart Hospital Baylor Plano
Plano, Texas, United States, 75093
Actively Recruiting
66
Methodist Hospital of San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
67
University of Virginia
Charlottesville, Virginia, United States, 22908
Actively Recruiting
68
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
Actively Recruiting
69
University of Wisconsin
Madison, Wisconsin, United States, 53792
Actively Recruiting
70
Advocate Aurora Research Institute
Milwaukee, Wisconsin, United States, 53215
Actively Recruiting
71
Vancouver General Hospital
Vancouver, British Columbia, Canada, V521M9
Actively Recruiting
72
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1y4W7
Actively Recruiting
73
Toronto General Hospital (UHN)
Toronto, Ontario, Canada, M5G 2C4
Actively Recruiting
74
CHUM
Montreal, Quebec, Canada, H2X 0C1
Actively Recruiting
75
IUCPQ-Ulaval
Québec, Quebec, Canada, G1V4G5
Actively Recruiting
76
Essex Cardiothoracic Centre
Basildon, United Kingdom, SS16 5NL
Actively Recruiting
77
Queen Elizabeth Hospital Birmingham
Birmingham, United Kingdom, B15 2GW
Actively Recruiting
78
Bristol Heart Institute
Bristol, United Kingdom, BS2 8HW
Actively Recruiting
79
Royal Papworth Hospital
Cambridge, United Kingdom, |CB2 0AY
Actively Recruiting
80
Dorset County Hospital NHS Foundation Trust
Dorchester, United Kingdom, DT1 2JY
Actively Recruiting
81
Kettering General Hospital
Kettering, United Kingdom, NN16 8UZ
Actively Recruiting
82
Glenfield Hospital, Leicester
Leicester, United Kingdom, LE3 9QP
Actively Recruiting
83
Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool, United Kingdom, L14 3PE
Actively Recruiting
84
Barts Health Centre
London, United Kingdom, E1 1FR
Actively Recruiting
85
Royal Free Hospital
London, United Kingdom, NW3 2QG
Actively Recruiting
86
St. Thomas Hospital
London, United Kingdom, SE1 7EH
Actively Recruiting
87
King's College Hospital
London, United Kingdom, SE5 9RS
Actively Recruiting
88
St. Georges University Hospital
London, United Kingdom, SW17 0QT
Actively Recruiting
89
Royal Brompton Hospital
London, United Kingdom, SW3 6NP
Actively Recruiting
90
Imperial College Healthcare NHS Trust
London, United Kingdom, W12 0HS
Actively Recruiting
91
Freeman Hospital
Newcastle upon Tyne, United Kingdom, NE7 7DN
Actively Recruiting
92
Nottingham University Hospital
Nottingham, United Kingdom, NG5
Actively Recruiting
93
Oxford University Hospital
Oxford, United Kingdom, OX3 9DU
Actively Recruiting
94
Royal Bournemouth Hospital
Poole, United Kingdom, BH15 2JB
Actively Recruiting
95
Musgrove Park Hospital
Taunton, United Kingdom, TA1 5DA
Actively Recruiting
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Research Team
C
COSIRA-II Study Team
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Published Research Related To This Trial
Post-PCI coronary physiology: clinical outcomes and can we optimize?
Maximillian T Bourdillon, Nils P Johnson, H V Skip Anderson
https://pubmed.ncbi.nlm.nih.gov/39668004How might coronary sinus reducer treatment change myocardial perfusion?
Robert M Bober, Nils P Johnson
https://pubmed.ncbi.nlm.nih.gov/38395338