NCT06898541: REDUCE CMD

Coronary Sinus Reducer in Coronary Microvascular Disease

ENROLLING BY INVITATION NA Last updated 4 December 2025

What this trial tests

NA trial testing Coronary sinus reducer in Angina (Stable) in 50 participants. Enrolling by invitation.

Timeline

20 November 2025

Primary endpoint
1 May 2028

1 November 2028

Quick facts

Lead sponsor	UMC Utrecht
Phase	NA
Status	ENROLLING BY INVITATION
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	50
Start date	20 November 2025
Primary completion	1 May 2028
Estimated completion	1 November 2028
Sites	2 locations across Netherlands

Drugs / interventions tested

• Coronary sinus reducer
• Sham CSR procedure

Conditions studied

• Angina (Stable) — all drugs for Angina (Stable) →
• Coronary Microvascular Disease — all drugs for Coronary Microvascular Disease →

Sponsor

UMC Utrecht — full company profile →

Who can join

40 and older, any sex, with Angina (Stable) or Coronary Microvascular Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Coronary Sinus Reduction for REDUCER-I Patients With Refractory Angina and Angiographically Nonobstructive Coronary Artery Disease.
   de Silva R, van de Hoef TP, van Kuijk JP, Byrne J, et al · · 2026 · PMID 41863985 · DOI 10.1016/j.jacadv.2026.102686