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Coronary Sinus Reducer in Coronary Microvascular Disease

NCT06898541 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-12-04

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Radboud University Medical Center

    collaborator OTHER

  • Maasstad Hospital, Rotterdam

    collaborator UNKNOWN

  • VieCuri, Venlo, the Netherlands

    collaborator UNKNOWN

  • UMC Utrecht

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-20
Primary Completion
2028-05-01
Completion
2028-11-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06898541 on ClinicalTrials.gov