Coronary Sinus Reducer Implantation in Patients With Ischaemia and Non-obstructed Coronary Arteries and Coronary Microvascular Dysfunction.
NCT05492110 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54
Last updated 2025-04-03
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.
Conditions
- Refractory Angina
- Microvascular Angina
- Microvascular Coronary Artery Disease
- Coronary Disease
- Angina Pectoris
Interventions
- DEVICE
-
Coronary sinus reducer
The 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.
- OTHER
-
Sham-procedure
Implantation procedure with no device implanted
- DIAGNOSTIC_TEST
-
Invasive coronary physiology
Invasive coronary physiology assessment as part of REMEDY-MECH mechanistic substudy
Sponsors & Collaborators
-
Bradford Teaching Hospitals NHS Foundation Trust
collaborator OTHER_GOV -
East and North Hertfordshire NHS Trust
collaborator OTHER_GOV -
Epsom and St Helier University Hospitals NHS Trust
collaborator OTHER -
Guy's and St Thomas' NHS Foundation Trust
collaborator OTHER -
Imperial College Healthcare NHS Trust
collaborator OTHER -
Kingston Hospital NHS Trust
collaborator OTHER -
London North West Healthcare NHS Trust
collaborator OTHER -
Oxford University Hospitals NHS Trust
collaborator OTHER -
Royal Brompton & Harefield NHS Foundation Trust
collaborator OTHER -
St George's University Hospitals NHS Foundation Trust
collaborator OTHER -
Liverpool University Hospitals NHS Foundation Trust
collaborator OTHER_GOV -
Imperial College London
lead OTHER
Principal Investigators
-
Ranil E de Silva, FRCP, PhD · Imperial College London
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-04-17
- Primary Completion
- 2026-03-06
- Completion
- 2026-03-06
Countries
- United Kingdom
Study Locations
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