Efficacy of the COronary SInus Reducer in Patients With Refractory Angina II (NCT05102019)
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Mayo Clinic โ Phoenix, Arizona
Age range: 18 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (96 Sites)
Showing the first 25 of 96 sites.
- Mayo Clinic โ Phoenix, Arizona
- HonorHealth Research Institute โ Scottsdale, Arizona
- University of Arizona Sarver Heart Center โ Tucson, Arizona
- Long Beach VA Medical Center โ Long Beach, California
- USC Keck School of Medicine โ Los Angeles, California
- Cedars-Sinai โ Los Angeles, California
- UCSD โ San Diego, California
- Kaiser Permanente San Francisco โ San Francisco, California
- UCSF โ San Francisco, California
- Los Robles Hospital and Medical Center โ Thousand Oaks, California
- South Denver Cardiology Associates โ Littleton, Colorado
- Yale University โ New Haven, Connecticut
- MedStar Cardiovascular Research Network โ Washington D.C., District of Columbia
- The Cardiac and Vascular Institute โ Gainesville, Florida
- UF Health Jacksonville โ Jacksonville, Florida
- Mount Sinai Miami โ Miami Beach, Florida
- NCH Healthcare - Naples โ Naples, Florida
- Ascension Sacred Heart โ Pensacola, Florida
- Tallahassee Research Institute โ Tallahassee, Florida
- Tampa General - USF Cardiology โ Tampa, Florida
- Emory Hospital โ Atlanta, Georgia
- Northside Hospital โ Atlanta, Georgia
- Northeast Georgia โ Gainsville, Georgia
- Wellstar Kennestone Hospital โ Marietta, Georgia
- Northwestern University โ Chicago, Illinois
๐ Contact the Study Coordinator
Phone: (888) 887-8097
Email: connect.cosira2@shockwavemedical.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Refractory Angina
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- Investigational Trial to Evaluate XC001 Delivered Via an Cardiac Catheter in Subjects With Chronic Angina. โ Cincinnati, Ohio
Explore by condition: All Refractory Angina clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.