NCT06898541Enrolling by invitation
Coronary Sinus Reducer in Coronary Microvascular Disease
Impact of the Coronary Sinus Reducer on Coronary Flow Reserve and Symptoms in Patients With Coronary Microvascular Disease
Source: ClinicalTrials.gov · Last updated 4 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 4 Jan 2025
- Start date
- 20 Nov 2025
- Primary completion date
- 1 May 2028
- Lead sponsor
- UMC Utrecht
- Diseases
- Coronary artery disease
- NCT number
- NCT06898541
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 20 Nov 2025 to the primary completion date, 1 May 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior positive acetylcholine provocation test with respect to epicardial vasospasm following the COVADIS criteria.
- 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).
- Contra-indication to short term dual antiplatelet therapy or lifelong aspirin treatment.
- 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.
Other illness
- Severe pulmonary hypertension.
- Recent acute coronary syndrome (within 3 months).
- Severe arrhythmias, including chronic atrial fibrillation with persistent rapid ventricular response (\>100bpm despite medication).
- Indication for cardiac resynchronization therapy.
- Severe valvular heart disease.
- History of tricuspid valve replacement or repair.
Lab values
- Severe left ventricular impairment (left ventricular ejection fraction \<35%).
Age
- Age \< 18 years.
Other
- 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.
- Mean right atrial pressure ≥15 mmHg
- Coronary sinus anatomy not suitable for CSR implantation.
- Pregnancy or planned pregnancy within the next 12 months.
- Recent revascularization with PCI (within 6 months).
- Presence of a pacemaker lead in the coronary sinus.
- Known inability to tolerate contrast medium.
- Life expectancy \<1 year.
Who the study is looking for
- 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.
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Maasstad Ziekenhuis Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Unknown status |
| UMC Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.