RecruitingNot ApplicableNCT04606459

COSIMA: COronary SInus Reducer for the Treatment of Refractory Microvascular Angina

A Multicentric Randomized Open Label Controlled Superiority Trial to Evaluate the Effectiveness of a Therapy With a Coronary Sinus Reducer as Compared to Guideline-directed Medical Therapy in Patients With Refractory Microvascular Angina

Sponsor

Johannes Gutenberg University Mainz

Enrollment

144 participants

Start Date

Apr 1, 2021

Study Type

INTERVENTIONAL

Conditions

Coronary microvascular disease Refractory Angina

Summary

Patients with refractory microvascular angina fulfilling the predefined inclusion and exclusion criteria will be enrolled in this randomized trial. The primary objective is to investigate whether the proportion of patients reporting an improvement in Canadian Cardiovascular Society (CCS) angina class (≥2 classes) is different at six months after implantation of a Coronary Sinus Reducer followed by optimal medical therapy (OMT) compared to OMT alone.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Coronary sinus reducer and Optimal medical therapy for people with coronary microvascular disease and refractory angina. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 85 Years.

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 Reducer System comprises the Reducer device (Reducer) pre-mounted on the Reducer Balloon Catheter. The Reducer System is available in one model size. The Reducer is a sterile, single-use, implantable device designed to establish a narrowing in the coronary sinus (CS) and is intended to improve perfusion to ischemic myocardium in the presence of reversible ischemic heart disease to alleviate the symptoms of refractory angina. The device is implanted percutaneously through the right internal jugular vein into the CS. The Reducer is pre-mounted (crimped) on the Reducer Balloon Catheter which, after inflation, causes device expansion and apposition with the vessel wall. The balloon catheter is then deflated and removed from the CS, leaving the device permanently implanted.

OTHEROptimal medical therapy

Guideline-directed medical therapy