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

Status: Recruiting
Location: See all (75) locations...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 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

• 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.

• 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

Locations
United States
Arizona
Mayo Clinic
RECRUITING
Phoenix
HonorHealth Research Institute
RECRUITING
Scottsdale
University of Arizona Sarver Heart Center
RECRUITING
Tucson
California
Long Beach VA Medical Center
RECRUITING
Long Beach
Cedars-Sinai
RECRUITING
Los Angeles
UCSD
RECRUITING
San Diego
Kaiser Permanente San Francisco
RECRUITING
San Francisco
Los Robles Hospital and Medical Center
RECRUITING
Thousand Oaks
Colorado
South Denver Cardiology Associates
RECRUITING
Littleton
Connecticut
Yale University
RECRUITING
New Haven
Washington, D.c.
MedStar Cardiovascular Research Network
RECRUITING
Washington D.c.
Florida
The Cardiac and Vascular Institute
RECRUITING
Gainesville
UF Health Jacksonville
RECRUITING
Jacksonville
Mount Sinai Miami
RECRUITING
Miami Beach
NCH Healthcare - Naples
RECRUITING
Naples
Ascension Sacred Heart
RECRUITING
Pensacola
Tallahassee Research Institute
RECRUITING
Tallahassee
Tampa General - USF Cardiology
RECRUITING
Tampa
Georgia
Emory Hospital
RECRUITING
Atlanta
Northside Hospital
WITHDRAWN
Atlanta
Northeast Georgia
RECRUITING
Gainesville
Wellstar Kennestone Hospital
RECRUITING
Marietta
Illinois
Northwestern University
RECRUITING
Chicago
Southern Illinois University
RECRUITING
Springfield
Indiana
Ascension St. Vincent Heart Center
RECRUITING
Carmel
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Cardiovascular Research Institute of Kansas
WITHDRAWN
Wichita
Louisiana
Cardiovascular Institute of the South
RECRUITING
Houma
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Baystate Medical Center
RECRUITING
Springfield
Michigan
University of Michigan
RECRUITING
Ann Arbor
Henry Ford Hospital
RECRUITING
Detroit
Henry Ford Providence
RECRUITING
Southfield
Minnesota
Minneapolis Heart Institute Foundation
RECRUITING
Minneapolis
Mayo Clinic
RECRUITING
Rochester
Missouri
Saint Luke's Hospital
RECRUITING
Kansas City
Mississippi
Jackson Heart Clinic
RECRUITING
Jackson
Cardiology Associates of North Mississippi
RECRUITING
Tupelo
North Carolina
Novant Health
RECRUITING
Charlotte
New Jersey
Hackensack University
RECRUITING
Hackensack
New York
Columbia University Medical Center/NYPH
RECRUITING
New York
Mount Sinai Medical Center
RECRUITING
New York
Weill Cornell Medicine
RECRUITING
New York
St. Francis Hospital
RECRUITING
Roslyn
Ohio
The Christ Hospital
RECRUITING
Cincinnati
Cleveland Clinic
RECRUITING
Cleveland
The Ohio State University
RECRUITING
Columbus
Oklahoma
Ascension St. John
RECRUITING
Tulsa
Oregon
Providence Heart Institute
RECRUITING
Portland
Pennsylvania
Allegheny General Hospital
RECRUITING
Pittsburgh
Tennessee
TriStar Centennial Medical Center
RECRUITING
Nashville
Vanderbilt Heart
RECRUITING
Nashville
Texas
Ascension Texas Cardiovascular
RECRUITING
Austin
Medical City Fort Worth
RECRUITING
Fort Worth
HCA Houston Healthcare Medical Center
WITHDRAWN
Houston
Houston Methodist
RECRUITING
Houston
Texas Heart Institute
RECRUITING
Houston
University of Texas Health Science Center at Houston
RECRUITING
Houston
The Heart Hospital Baylor Plano
RECRUITING
Plano
Methodist Hospital of San Antonio
RECRUITING
San Antonio
Virginia
Sentara Norfolk General Hospital
RECRUITING
Norfolk
Wisconsin
University of Wisconsin
RECRUITING
Madison
Advocate Aurora Research Institute
RECRUITING
Milwaukee
Other Locations
Canada
CHUM
RECRUITING
Montreal
University of Ottawa Heart Institute
RECRUITING
Ottawa
IUCPQ-Ulaval
RECRUITING
Québec
Toronto General Hospital (UHN)
RECRUITING
Toronto
Vancouver General Hospital
RECRUITING
Vancouver
United Kingdom
Essex Cardiothoracic Centre
RECRUITING
Basildon
Bristol Heart Institute
RECRUITING
Bristol
Dorset County Hospital NHS Foundation Trust
RECRUITING
Dorchester
Liverpool Heart and Chest Hospital NHS Foundation Trust
RECRUITING
Liverpool
Imperial College Healthcare NHS Trust
RECRUITING
London
King's College Hospital
RECRUITING
London
Contact Information
Primary
COSIRA-II Study Team
connect.cosira2@shockwavemedical.com
Fax: 1-888-887-8097
Time Frame
Start Date: 2022-01-04
Estimated Completion Date: 2032-01
Participants
Target number of participants: 380
Treatments
Experimental: Arm 1 (treatment arm):Implantation of the Reducer device
Sham_comparator: Arm 2 (sham-control arm): Control (no device implantation)
Other: Arm 3 (unblinded, non-randomized): Single Arm Registry
Related Therapeutic Areas
Sponsors
Leads: Shockwave Medical, Inc.

This content was sourced from clinicaltrials.gov