Study of the Shockwave Reducer Device for Treating Adults With Refractory Angina Not Suitable for Revascularization

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the Shockwave Reducer device in patients with refractory angina pectoris who have persistent symptoms despite receiving the best medical therapy. This study includes a randomized, double-blinded, sham-controlled trial as well as a non-randomized registry for specific patient groups, such as those with right coronary artery ischemia or those unable to complete exercise tests. The trial aims to compare outcomes between patients receiving the device implant and those undergoing a sham procedure, focusing on those unsuitable for standard revascularization procedures. Participants in the randomized trial will be assigned to either receive the Shockwave Reducer implant or a sham implantation procedure without the device. Patients in the single-arm registry will receive the Shockwave Reducer device without randomization. The study involves detailed assessments including coronary angiography and functional tests to confirm eligibility. The treatment period and follow-up extend through six months to evaluate both safety and effectiveness outcomes. During the study, participants will undergo multiple evaluations including stress tests, imaging, and clinical assessments to monitor angina symptoms and cardiac function. Researchers will track key outcomes such as angina severity scores and safety endpoints at six months. Participants are expected to comply with follow-up visits and stable medication regimens, and the study includes careful monitoring to ensure adherence and collect comprehensive data on the devices impact on refractory angina symptoms.

Efficacy of the COronary SInus Reducer in Patients With Refractory Angina II