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

NARecruitingINTERVENTIONAL
Enrollment

144

Participants

Timeline

Start Date

April 1, 2021

Primary Completion Date

October 20, 2025

Study Completion Date

October 20, 2029

Conditions
Coronary Microvascular DiseaseRefractory Angina
Interventions
DEVICE

Coronary 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.

OTHER

Optimal medical therapy

Guideline-directed medical therapy

Trial Locations (1)

55131

RECRUITING

Center of Cardiology, Cardiology I, university hospital Mainz, Mainz

All Listed Sponsors
collaborator

Shockwave Medical, Inc.

INDUSTRY

lead

Johannes Gutenberg University Mainz

OTHER