Randomized Study Comparing Coronary Sinus Reducer Implantation to Standard Medical Therapy for Treating Patients With Refractory Microvascular Angina

What this Trial Is About

Researchers are investigating treatments for refractory microvascular angina, a common condition where small vessels in the heart do not work properly, causing chest pain. This trial aims to compare whether using a Coronary Sinus Reducer device plus optimal medical therapy improves symptoms more than medical therapy alone. Microvascular angina affects many patients with chest pain but no major artery blockages, posing challenges for effective treatment and increasing risks of hospitalizations and poor quality of life. The study compares two groups one receiving optimal medical therapy following European guidelines, including medications like aspirin, statins, beta-blockers, and calcium channel blockers, and the other receiving the same medical therapy plus implantation of the Neovasc Reducer device. This device is placed in the coronary sinus vein via a minimally invasive procedure to improve blood flow to the heart muscle. The trial is randomized and open-label, with careful monitoring of the device implantation success and treatment effects. Participants will be followed for at least six months to assess changes in angina severity using the Canadian Cardiovascular Society angina classification and other questionnaires on quality of life and symptom frequency. Researchers will also track emergency visits, hospitalizations, and adverse events over several years. The study includes detailed clinical assessments and aims to provide evidence on the potential benefits of the device for patients whose symptoms do not improve with medication alone.

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