Coronary Sinus Reducer in Coronary Microvascular Disease

Not Applicable

Not yet recruiting

• Conditions: Angina (Stable); Coronary Microvascular Disease

• Registration Number: NCT06898541
• Lead Sponsor: UMC Utrecht

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-04
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-26
• Last Update Submitted: 2025-03-26
• Study First Posted: 2025-03-27
• Last Update Posted: 2025-03-27
• Study Start: 2025-05-01
• Primary Completion: 2028-05-01
• Study Completion: 2028-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Coronary microvascular dysfunction 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 hyperemia.
2. No hemodynamically significant epicardial stenoses based on both non-hyperemic pressure ratio (NHPR; iFR&gt;0.89, or RFR&gt;0.89, or dFR&gt;0.89) and fractional flow reserve (FFR&gt;0.80) assessments.
3. Angina - Canadian Cardiovascular Society Class II-IV on maximal medical therapy.
4. Negative acetylcholine provocation testing with respect to epicardial or microvascular vasospasm (as such, patients with equivocal acetylcholine provocation test results are not eligible for enrolment).
5. Patient understands the nature of the procedure and provides written informed consent prior to enrolment.
6. Patient is willing to comply with specified follow-up evaluation.

Exclusion Criteria

1. Age ≤ 40 years.
2. Pregnancy.
3. Recent acute coronary syndrome (within 3 months).
4. Recent revascularization with PCI (within 6 months).
5. Severe arrhythmias, including chronic atrial fibrillation.
6. Severe left ventricular impairment (left ventricular ejection fraction &lt;25%).
7. Permanent pacemaker or defibrillator leads in the right ventricle or atrium.
8. Indication for cardiac resynchronization therapy.
9. Severe valvular heart disease.
10. History of tricuspid valve replacement or repair.
11. Mean right atrial pressure ≥15 mm Hg.
12. Known allergy to stainless steel or nickel.
13. Anomalous or abnormal CS anatomy (e.g., tortuosity, aberrant branch, persistent left superior vena cava).
14. CS diameter at the site of planned implantation greater than 13mm or less than 9.5mm as measured on the venogram.
15. 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.
16. Life expectancy <1 year.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in coronary flow reserve	6 months	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).
Angina episodes	6 months	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.