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.
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.
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)
Parallel
Coronary sinus reducer
DeviceThe Neovasc coronary sinus reducer is an hourglass-shaped stainless steel device inserted percutaneously into the coronary sinus and currently indicated for the treatment of refractory angina.
Sham-procedure
Other interventionImplantation procedure with no device implanted
Invasive coronary physiology
Diagnostic testInvasive coronary physiology assessment as part of REMEDY-MECH mechanistic substudy
number of patients consenting to participate in the study.
Consent rate
Premature withdrawal rate including reasons for withdrawal
Registry of patients either failing screening or unwilling to consent to full trial
Change in myocardial perfusion
Change at 6 months post randomisation, compared to baseline, in quantitative myocardial perfusion (global myocardial perfusion reserve \[MPR\]) assessed by cardiac MRI.
Canadian Cardiovascular Society (CCS) Angina Score
Change in CCS class from baseline to 6 months post-randomisation. The CCS grading system for angina is a clinical tool used by doctors to assess the degree of severity of a patient's angina. Possible scores range from Class 0 (asymptomatic angina) to Class IV (angina at rest).
Seattle Angina Questionnaire (SAQ) score
Change in SAQ score from baseline to 6 months. The Seattle Angina Questionnaire (SAQ) is a disease-specific questionnaire used to quantify patients' symptoms of angina and the extent to which their angina affects their functioning and quality of life. Possible scores range from 0 (daily angina) to 100 (no angina). Lower scores indicate worse angina symptoms.
Short-form 36 (SF-36)
Change in SF-36 scores from baseline to 6 months. Validated questionnaire to assess quality of life. 36 items each scored from 0-100 with higher scores indicating a more favourable health state.
Hospital Anxiety and Depression Scale (HADS)
Change in HADS score from baseline to 6 months. Scores range from 0 to 21. Normal results are indicated by lower scores. Validated questionnaire to assess psychological wellbeing.
Change in absolute global myocardial perfusion (ml/min/g) at rest and during adenosine stress (transmural, endocardial, epicardial) from baseline to 6 months post-randomisation
Change in absolute myocardial perfusion (ml/min/g) at rest and during adenosine stress (transmural, endocardial, epicardial) from baseline to 6 months post-randomisation in the distribution territory of the left coronary circulation.
Change in global endocardial:epicardial perfusion ratio at rest and after adenosine stress from baseline to 6 months post-randomisation
Change in endocardial:epicardial perfusion ratio at rest and after adenosine stress from baseline to 6 months post-randomisation in the distribution territory of the left coronary circulation.
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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
