Coronary Sinus Reducer in Coronary Microvascular Disease

Launched by UMC UTRECHT · Mar 26, 2025

Keywords

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Gender

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Eligibility criteria

• 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.