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 range18 Years
SexALL
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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.
Exclusion criteria
✕. 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
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
. 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