Coronary Sinus Reducer Implantation in Patients With Ischaemia and Non-obstructed Coronary Arteri… (NCT05492110) | Clinical Trial Compass
RecruitingNot Applicable
Coronary Sinus Reducer Implantation in Patients With Ischaemia and Non-obstructed Coronary Arteries and Coronary Microvascular Dysfunction.
United Kingdom54 participantsStarted 2023-04-17
Plain-language summary
To demonstrate the feasibility and efficacy of the CS Reducer for the treatment of patients with ischaemia and non-obstructed coronary arteries (INOCA) and coronary microvascular dysfunction (CMD) and through a nested mechanistic substudy investigate the physiological responses in the coronary microcirculation responsible for changes in myocardial perfusion.
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
. Age \>18 years
. Ongoing symptomatic angina, CCS Class II-IV, for ≥3 months despite background treatment with at least two anti-anginal drug at the maximal tolerated dose.
. Patients willing to consider no change in anti-anginal drug treatment for the duration of their participation in the trial.
. Unobstructed coronary arteries with ≤50% epicardial stenoses demonstrated on coronary angiography.
. Stress-induced hypoperfusion on CMR (Global MPR ≤ 2.2).
. Willingness to comply with the specified follow-up evaluation and to be contactable during the period of the trial.
. Understands the nature of the trial procedures and provides written informed consent.
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.
What they're measuring
1
number of patients consenting to participate in the study.
Timeframe: 6 months
2
Premature withdrawal rate including reasons for withdrawal
. Epicardial CAD in a main coronary artery (stenoses \>50%, RFR≤0.92 or FFR≤0.80), coronary artery bypass grafting, or myocardial infarction (MI).
. Previous PCI within 6 months
. PCI with stent insertion for acute MI or chronic total occlusion (CTO)
. Abnormal coronary sinus anatomy (tortuosity, aberrant branch, persistent left superior vena cava)
. Coronary sinus diameter at site of implant \<9.5mm or \>13mm
. Mean right atrial pressure \<15mmHg at time of implantation
. Any structural heart disease including left ventricular hypertrophy; cardiomyopathy; severe valvular heart disease; previous valve replacement; myocardial bridge on angiography; LVEF\<45% by CMR.
. Clinically or angiographically diagnosed coronary vasospasm