Coronary Sinus Reducer in Coronary Microvascular Disease
Launched by UMC UTRECHT · Mar 26, 2025
Trial Information
Current as of April 23, 2025
Not yet recruiting
Keywords
ClinConnect Summary
No description provided
Gender
ALL
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\>0.89, or RFR\>0.89, or dFR\>0.89) and fractional flow reserve (FFR\>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 \<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.
About Umc Utrecht
UMC Utrecht is a leading academic medical center in the Netherlands, renowned for its commitment to innovative research and high-quality patient care. As a prominent sponsor of clinical trials, UMC Utrecht leverages its extensive expertise in translational medicine and collaboration with various stakeholders to advance medical knowledge and improve therapeutic outcomes. The institution emphasizes ethical conduct and rigorous scientific standards, ensuring that all research activities contribute meaningfully to the global healthcare landscape. Through its robust clinical trial infrastructure, UMC Utrecht plays a vital role in facilitating the development of new treatments and enhancing patient wellbeing.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported