RecruitingNot ApplicableNCT05492110

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

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

Sponsor

Imperial College London

Enrollment

54 participants

Start Date

Apr 17, 2023

Study Type

INTERVENTIONAL

Conditions

Coronary Disease Angina Pectoris Microvascular Coronary Artery Disease Microvascular Angina Refractory Angina

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Coronary sinus reducer, Invasive coronary physiology, and others for people with angina pectoris, coronary disease, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECoronary 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.

OTHERSham-procedure

Implantation procedure with no device implanted

DIAGNOSTIC_TESTInvasive 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, United Kingdom

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NCT05492110

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