Coronary Sinus Reducer in Coronary Microvascular Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Coronary sinus reducer, Sham CSR procedure.
- Who it may be relevant to
- Registry conditions: Angina (Stable), Coronary Microvascular Disease. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of the Coronary Sinus Reducer on Coronary Flow Reserve and Symptoms in Patients With Coronary Microvascular Disease
Overview
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.
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.
Primary outcome measures
- Change in coronary flow reserve [Time frame: 6 months]
- Angina episodes [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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).
- Presence of a pacemaker lead in the coronary sinus.
- Severe valvular heart disease.
- History of tricuspid valve replacement or repair.
- 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.
- Known inability to tolerate contrast medium.
- Life expectancy <1 year.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Netherlands · 2 centers
- Maasstad Ziekenhuis — Rotterdam
- UMC Utrecht — Utrecht
Identifiers
NCT: NCT06898541 · REDUCE CMD