Coronary Sinus Reducer Therapy for Persisting Angina
25 participantsStarted 2026-04-01
Plain-language summary
Refractory angina due to advanced obstructive coronary artery disease (CAD) remains a major clinical problem with limited evidence-based treatment options. The coronary sinus reducer (CSR) is an hourglass-shaped stainless-steel mesh device designed to create a controlled narrowing of the coronary sinus (CS). By increasing CS pressure, CSR implantation may improve myocardial perfusion and reduce anginal symptoms, although the physiological mechanisms underlying this effect remain incompletely understood.
REDUCE-ANGINA is a prospective observational study investigating the hemodynamic effects of CSR implantation in 25 patients with refractory angina and advanced CAD. The study evaluates the interaction between coronary sinus hemodynamics and coronary arterial blood flow before and after CSR implantation. The main study endpoints include changes in coronary sinus pressure, coronary flow reserve, microvascular resistance reserve, and absolute microvascular resistance from baseline to 6 months, measured using continuous flow thermodilution during saline-induced coronary hyperemia.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Angina - Canadian Cardiovascular Society Class II-IV on at least two anti-anginals or maximally tolerated medical therapy if less than two.Hemodynamically significant epicardial coronary artery disease in the LAD, defined as an FFR≤0.80 and/or NHPR≤0.89.
* No conventional revascularization options or considered unsuitable as determined by the local heart team.
* Anatomically suitable for instrumentation of the left anterior descending coronary artery with a coronary pressure wire and infusion microcatheter.
* 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.
* 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 \<30%).
* NYHA class IV or decompensated heart failure or hospitalization due to heart failure within 90 days before the index procedure.
* Recent implantation…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.