144
Participants
Start Date
April 1, 2021
Primary Completion Date
October 20, 2025
Study Completion Date
October 20, 2029
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.
Optimal medical therapy
Guideline-directed medical therapy
RECRUITING
Center of Cardiology, Cardiology I, university hospital Mainz, Mainz
Shockwave Medical, Inc.
INDUSTRY
Johannes Gutenberg University Mainz
OTHER