Coronary Sinus Reducer Implantation in Patients With Ischaemia and Non-obstructed Coronary Arteries and Coronary Microvascular Dysfunction.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorImperial College London

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

54 Participants
are divided into 2 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