NCT06898541

Coronary Sinus Reducer in Coronary Microvascular Disease

Impact of the Coronary Sinus Reducer on Coronary Flow Reserve and Symptoms in Patients With Coronary Microvascular Disease

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: UMC Utrecht · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Angina (Stable)
• Coronary Microvascular Disease

Interventions

Type	Name	Description
DEVICE	Coronary sinus reducer	Implantation of a Coronary Sinus Reducer device
OTHER	Sham CSR procedure	Patients will undergo a complete sham CSR implantation procedure without actual deployment of the CSR.

Timeline

• Start date: 2025-11-20
• Primary completion: 2028-05-01
• Completion: 2028-11-01
• First posted: 2025-03-27
• Last updated: 2025-12-04

Locations

2 sites across 1 country: Netherlands