Coronary Sinus Reducer in Coronary Microvascular Disease

NCT06898541 | Enrolling By Invitation DMC

• 1 other identifier: REDUCE CMD
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Angina; Coronary microvascular disease; Coronary sinus reducer

Outcome Measures

Primary Outcomes (2)

• Change in coronary flow reserve

  Change in coronary flow reserve from baseline to 6 months in the CSR-arm versus the placebo arm (measured by the continuous flow thermodilution technique using saline-induced coronary hyperaemia).

  6 months

• Angina episodes

  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.

  6 months

Study Arms (2)

Sham

SHAM COMPARATOR

Patients in this arm undergo a sham CSR procedure.

Other: Sham CSR procedure

CSR arm

EXPERIMENTAL

Patients in this arm undergo coronary sinus reducer implantation.

Device: Coronary sinus reducer

Interventions

Sham CSR procedure OTHER

Patients will undergo a complete sham CSR implantation procedure without actual deployment of the CSR.

Also known as: Sham

Sham

Coronary sinus reducer DEVICE

Implantation of a Coronary Sinus Reducer device

Also known as: reducer

CSR arm

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Coronary microvascular dysfunction in the left anterior descending coronary artery (LAD) as expressed by abnormal absolute coronary flow reserve (CFR\<2.5) confirmed during the index study procedure using the continuous thermodilution technique and saline-induced coronary hyperaemia.
• Angina - Canadian Cardiovascular Society Class II-IV on at least two anti-anginals or maximally tolerated medical therapy if less than two.
• Patient understands the nature of the procedure and provides written informed consent for the study prior to enrolment.

You may not qualify if:

• Age \< 18 years.
• Absence of symptoms reported on the ORBITA-app during the 2-week screening period.
• Presence of hemodynamically significant epicardial stenoses based on both non- hyperaemic pressure ratio (NHPR; iFR≤0.89, or RFR≤0.89, or dFR/dPR≤0.89) or fractional flow reserve (FFR≤0.80) assessments.
• Prior positive acetylcholine provocation test with respect to epicardial vasospasm following the COVADIS criteria.
• Mean right atrial pressure ≥15 mmHg
• Severe pulmonary hypertension.
• Coronary sinus anatomy not suitable for CSR implantation.
• Pregnancy or planned pregnancy within the next 12 months.
• Recent acute coronary syndrome (within 3 months).
• Recent revascularization with PCI (within 6 months).
• Severe arrhythmias, including chronic atrial fibrillation with persistent rapid ventricular response (\>100bpm despite medication).
• Indication for cardiac resynchronization therapy.
• Severe left ventricular impairment (left ventricular ejection fraction \<35%).
• NYHA class IV or decompensated heart failure or hospitalization due to heart failure within 90 days before the index procedure.
• Recent implantation of a permanent pacemaker or defibrillator lead in the right ventricle or atrium (within 90 days before the index procedure).

Sponsors & Collaborators

• UMC Utrecht: lead
• Radboud University Medical Center: collaborator
• Maasstad Hospital, Rotterdam: collaborator
• VieCuri, Venlo, the Netherlands: collaborator

Study Sites (2)

Maasstad Ziekenhuis

Rotterdam, Netherlands

Location

UMC Utrecht

Utrecht, 3584CX, Netherlands

Location

MeSH Terms

Conditions

Angina, Stable; Microvascular Angina; Angina Pectoris

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 4, 2025
• First Posted: March 27, 2025
• Study Start: November 20, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)