About this trial
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
Qualifiers
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.
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Coronary sinus reducer
- Sham-procedure
- Invasive coronary physiology
Treatment groups
Sponsors and collaborators
Imperial College London
Lead sponsor
Bradford Teaching Hospitals NHS Foundation Trust
Collaborator
East and North Hertfordshire NHS Trust
Collaborator
Epsom and St Helier University Hospitals NHS Trust
Collaborator
Guy's and St Thomas' NHS Foundation Trust
Collaborator
Imperial College Healthcare NHS Trust
Collaborator
Kingston Hospital NHS Trust
Collaborator
London North West Healthcare NHS Trust
Collaborator
Oxford University Hospitals NHS Trust
Collaborator
Royal Brompton & Harefield NHS Foundation Trust
Collaborator
St George's University Hospitals NHS Foundation Trust
Collaborator
Liverpool University Hospitals NHS Foundation Trust
Collaborator