Condition: Refractory Angina · Sponsor: Shockwave Medical, Inc.
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.
This description comes directly from the study's public registry record.
COSIRA-II Study Team · Fax: 1-888-887-8097 · connect.cosira2@shockwavemedical.com
Always discuss trial participation with your own doctor first.
| Mayo Clinic | Phoenix, Arizona, United States | Recruiting |
| HonorHealth Research Institute | Scottsdale, Arizona, United States | Recruiting |
| University of Arizona Sarver Heart Center | Tucson, Arizona, United States | Recruiting |
| Long Beach VA Medical Center | Long Beach, California, United States | Withdrawn |
| Cedars-Sinai | Los Angeles, California, United States | Recruiting |
| UCSD | San Diego, California, United States | Recruiting |
| Kaiser Permanente San Francisco | San Francisco, California, United States | Recruiting |
| UCSF | San Francisco, California, United States | Recruiting |
| Los Robles Hospital and Medical Center | Thousand Oaks, California, United States | Recruiting |
| South Denver Cardiology Associates | Littleton, Colorado, United States | Recruiting |
| Yale University | New Haven, Connecticut, United States | Recruiting |
| MedStar Cardiovascular Research Network | Washington D.C., District of Columbia, United States | Recruiting |
+ 83 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05102019