COSIRA-II (NCT05102019)

Efficacy of the COronary Sinus Reducer in Patients with Refractory Angina II

PI: Emerson Perin, MD, PhD

Sponsor: Shockwave

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To demonstrate the safety and effectiveness of the Reducer system 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.

Eligibility Requirements

1. Subject is older than 18 years of age.

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.

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.

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.

5. Left ventricular ejection fraction (LVEF) greater than or equal to 30% within the 12 months prior to enrollment.