Actively Recruiting
Coronary Sinus Reducer Implantation in Patients With Ischaemia and Non-obstructed Coronary Arteries and Coronary Microvascular Dysfunction.
Led by Imperial College London · Updated on 2025-04-03
54
Participants Needed
1
Research Sites
150 weeks
Total Duration
On this page
Sponsors
I
Imperial College London
Lead Sponsor
B
Bradford Teaching Hospitals NHS Foundation Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Coronary Sinus Reducer Implantation in Patients With Ischaemia and Non-obstructed Coronary Arteries and Coronary Microvascular Dysfunction.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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
- Previous hospitalisation for decompensated heart failure
- Pacemaker or defibrillator electrode in the right atrium, right ventricle or coronary sinus
- Documented arrhythmia requiring planned implantation of a permanent pacemaker or defibrillator
- Chronic kidney disease (creatinine >200 micromol/L; established on renal replacement therapy; functioning renal transplant)
- Haemoglobin <80g/L
- Contraindications to receiving dual antiplatelet therapy
- Severe chronic obstructive pulmonary disease (FEV1 <55% predicted)
- Moribund patients with life expectancy < 1year
- Known allergy to nickel or steel
- Current enrolment in another investigational device or drug trial
- Contraindications to CMR or receiving intravenous adenosine
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Heart and Lung Institute (Brompton Campus), Imperial College London
London, United Kingdom, SW36NP
Actively Recruiting
Research Team
R
Ranil de Silva, FRCP, PhD
CONTACT
K
Kevin Cheng, BM BCh, MRCP
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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