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NCT05492110
Coronary Sinus Reducer Implantation in Patients With Ischaemia and Non-obstructed Coronary Arteries and Coronary Microvascular Dysfunction.
Conditions: Refractory Angina, Microvascular Angina, Microvascular Coronary Artery Disease, Coronary Disease, Angina Pectoris, INOCA (Ischemia With Non Obstructive Coronary Artery Disease), ANOCA - Angina With Non-obstructive Coronary Arteries, Coronary Microvascular Dysfunction (CMD)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 54
Sponsor: Imperial College London
Location: National Heart and Lung Institute (Brompton Campus), Imperial College London London London
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.
Eligibility Criteria
Inclusion Criteria:
1. Age \>18 years
2. Ongoing symptomatic angina, CCS Class II-IV, for ≥3 months despite background treatment with at least two anti-anginal drugs at the maximal tolerated dose.
3. Patients willing to consider no change in anti-anginal drug treatment for the duration of their participation in the trial.
4. Unobstructed coronary arteries with ≤50% epicardial stenoses demonstrated on coronary angiography.
5. Stress-induced hypoperfusion on CMR (Global MPR ≤ 2.2).
6. Willingness to comply with the specified follow-up evaluation and to be contactable during the period of the trial.
7. Understands the nature of the trial procedures and provides written informed consent.
Exclusion Criteria:
1. Epicardial CAD in a main coronary artery (stenoses \>50%, RFR≤0.92 or FFR≤0.80), percutaneous coronary intervention (PCI; within previous 6 months, stent insertion for acute Type 1 MI or chronic total occlusion (CTO)), coronary artery bypass grafting, or confirmed Type 1 myocardial infarction (MI).
2. Abnormal coronary sinus anatomy (tortuosity, aberrant branch, persistent left superior vena cava)
3. Coronary sinus diameter unsuitable for device implantation at operator discretion
4. Mean right atrial pressure \>15mmHg at time of implantation
5. Structural heart disease including left ventricular hypertrophy with raised LV mass index; cardiomyopathy; severe valvular heart disease; previous valve replacement; significant myocardial bridge on angiography; LVEF\200 micromol/L; established on renal replacement therapy; functioning renal transplant)
11. Haemoglobin \
Source: ClinicalTrials.gov (NCT05492110). StuddyBuddy aggregates publicly available trial information.
