COSIMA: COronary SInus Reducer for the Treatment of Refractory Microvascular Angina
Recruiting
N/A
Interventional Study
Coronary Microvascular Disease
Refractory Angina
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 85
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 144 (estimated)
- Sponsor
- Johannes Gutenberg University Mainz · Other
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About This Trial
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…
Trial Locations
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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 diagn…
Contacts