Coronary Sinus Reducer in Coronary Microvascular Disease

NCT ID: NCT06898541

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-20
• Study Completion Date: 2028-11-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Sham

Patients in this arm undergo a sham CSR procedure.

Group Type: SHAM_COMPARATOR

Sham CSR procedure

Intervention Type: OTHER

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

CSR arm

Patients in this arm undergo coronary sinus reducer implantation.

Group Type: EXPERIMENTAL

Coronary sinus reducer

Intervention Type: DEVICE

Implantation of a Coronary Sinus Reducer device

Interventions

Coronary sinus reducer

Implantation of a Coronary Sinus Reducer device

Intervention Type: DEVICE

Sham CSR procedure

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

Intervention Type: OTHER

Other Intervention Names

reducer; Sham

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Angina - Canadian Cardiovascular Society Class II-IV on at least two anti-anginals or maximally tolerated medical therapy if less than two.

3. Patient understands the nature of the procedure and provides written informed consent for the study prior to enrolment.

Exclusion Criteria

1. Age < 18 years.

2. Absence of symptoms reported on the ORBITA-app during the 2-week screening period.

3. 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.

4. Prior positive acetylcholine provocation test with respect to epicardial vasospasm following the COVADIS criteria.

5. Mean right atrial pressure ≥15 mmHg

6. Severe pulmonary hypertension.

7. Coronary sinus anatomy not suitable for CSR implantation.

8. Pregnancy or planned pregnancy within the next 12 months.

9. Recent acute coronary syndrome (within 3 months).

10. Recent revascularization with PCI (within 6 months).

11. Severe arrhythmias, including chronic atrial fibrillation with persistent rapid ventricular response (>100bpm despite medication).

12. Indication for cardiac resynchronization therapy.

13. Severe left ventricular impairment (left ventricular ejection fraction <35%).

14. NYHA class IV or decompensated heart failure or hospitalization due to heart failure within 90 days before the index procedure.

15. Recent implantation of a permanent pacemaker or defibrillator lead in the right ventricle or atrium (within 90 days before the index procedure).

16. Presence of a pacemaker lead in the coronary sinus.

17. Severe valvular heart disease.

18. History of tricuspid valve replacement or repair.

19. Contra-indication to short term dual antiplatelet therapy or lifelong aspirin treatment.

20. Currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.

21. Known inability to tolerate contrast medium.

22. Life expectancy <1 year.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: collaborator

Maasstad Hospital, Rotterdam

UNKNOWN

Sponsor Role: collaborator

VieCuri, Venlo, the Netherlands

UNKNOWN

Sponsor Role: collaborator

UMC Utrecht

OTHER

Sponsor Role: lead

Responsible Party

Tim P. van de Hoef

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Maasstad Ziekenhuis

Rotterdam, , Netherlands

UMC Utrecht

Utrecht, , Netherlands

Countries

Netherlands

Other Identifiers

REDUCE CMD

Identifier Type: -

Identifier Source: org_study_id