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ACTIVE NOT RECRUITING
NCT05492110
NA

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

Sponsor: Imperial College London

View on ClinicalTrials.gov

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.

Official title: REducing Microvascular Dysfunction in Patients With Angina, Ischaemia and unobstructED coronarY Arteries - a PILOT Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

54

Start Date

2023-04-17

Completion Date

2026-08-05

Last Updated

2026-08-17

Healthy Volunteers

No

Interventions

DEVICE

Coronary sinus reducer

The Shockwave 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

Locations (1)

National Heart and Lung Institute (Brompton Campus), Imperial College London

London, London, United Kingdom