COSIMA: COronary SInus Reducer for the Treatment of Refractory Microvascular Angina
Trial Parameters
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Brief Summary
Patients with refractory microvascular angina fulfilling the predefined inclusion and exclusion criteria will be enrolled in this randomized trial. The primary objective is to investigate whether the proportion of patients reporting an improvement in Canadian Cardiovascular Society (CCS) angina class (≥2 classes) is different at six months after implantation of a Coronary Sinus Reducer followed by optimal medical therapy (OMT) compared to OMT alone.
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 and ≤85 years * Chronic coronary syndrome (including patients with anginal equivalents) refractory angina CCS class III-IV despite guideline-directed medical therapy * Evidence of reversible ischemia on non-invasive testing * Evidence of microvascular disease as diagnosed invasively by at least one of the following: 1. index of microvascular resistances (IMR) \>25 and/or 2. coronary flow reserve (CFR) \<2.0) with fractional flow reserve (FFR)\>0.8. * Willingness to participate and ability to understand, read and sign the informed consent document before enrollment in the trial. Exclusion Criteria: Subjects presenting at least one of the following criteria will not be enrolled in the trial * Recent (within 3 months) acute coronary syndrome * Recent (within 6 months) revascularization by percutaneous coronary intervention (PCI, stent) or coronary artery by-pass surgery (CABG) * Recent (within 30 days) unsuccessful PCI * Decompensated congestive heart failur