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Coronary Sinus Reducer in Coronary Microvascular Disease (REDUCE CMD)

NCT06898541 NA ENROLLING_BY_INVITATION

Coronary microvascular dysfunction (CMD) is a common cause of treatment- resistant angina that lacks evidence-based treatment options. The coronary sinus reducer (CSR) is an hourglass-shaped stainless steel mesh, designed to create a controlled narrowing of the coronary sinus (CS). By augmenting CS pressure, CSR implantation was shown to improve myocardial perfusion, potentially providing a novel treatment for patients with CMD. REDUCE CMD is a placebo-controlled study of CSR in 50 patients with CMD. The main study endpoints are the change in coronary flow reserve from baseline to 6 months in the CSR-arm versus the placebo arm, and the difference in number of daily episodes of angina recorded on the ORBITA-app at 6 month follow-up in the CSR-arm versus the placebo arm.

Details

Lead sponsorUMC Utrecht
PhaseNA
StatusENROLLING_BY_INVITATION
Enrolment50
Start dateThu Nov 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time)
CompletionWed Nov 01 2028 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Interventions

Countries

Netherlands