Coronary Sinus Reducer in Coronary Microvascular Disease

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.

NCT Number	NCT06898541
Lead Sponsor	UMC Utrecht Collaborators: Radboud University Medical Center, Maasstad Hospital, Rotterdam, VieCuri, Venlo, the Netherlands
Conditions	Angina (Stable), Coronary Microvascular Disease
Enrollment	50 participants
Start Date	2025-11-20
Primary Completion	2028-05-01 (estimated)
Study Completion	2028-11-01 (estimated)
Updated on ClinicalTrials.gov	2025-12-04