Status:
ENROLLING_BY_INVITATION
Coronary Sinus Reducer in Coronary Microvascular Disease
Lead Sponsor:
UMC Utrecht
Collaborating Sponsors:
Radboud University Medical Center
Maasstad Hospital, Rotterdam
Conditions:
Angina (Stable)
Coronary Microvascular Disease
Eligibility:
All Genders
40+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2028
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06898541
Start Date
November 20 2025
End Date
November 1 2028
Last Update
December 4 2025
Active Locations (2)
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1
Maasstad Ziekenhuis
Rotterdam, Netherlands
2
UMC Utrecht
Utrecht, Netherlands, 3584CX