Efficacy of the COronary SInus Reducer in Patients with Refractory Angina II (COSIRA-II)

Research summary

This study is designed for the patients with coronary artery disease (CAD) who experience severe chest pain (refractory angina) despite taking the best available medications. These patients also have evidence of reversible Ischemia (reduced blood flow), but they are considered high-risk or unsuitable for heart surgery or other currently available medical procedures aimed at restoring blood flow (revascularization procedures). A heart team, including specialists such as cardiologists and surgeons, helps determine their eligibility for the study. Shockwave Medical, Inc. has developed Shockwave Reducer™ System, designed to help these patients. The Reducer is a small, implantable device intended to improve blood flow to areas of the heart that are not getting enough oxygen. It works by creating a controlled narrowing in a blood vessel called the coronary sinus, which can help reduce the symptoms of angina. The device is inserted through a vein in the neck using a catheter and is permanently placed in the heart. About 380 participants will be enrolled from up to 75 sites in the United States and up to 25 international sites in Canada, the United Kingdom, and the European Union. Patients will be followed for a long period, with check-ins after hospital discharge, and at 30 days, 90 days, 6 months, and yearly for up to 5 years. Additionally, up to 270 patients may be enrolled in a separate registry for further observation. The study aims to determine if this device can effectively help patients who have limited treatment options for their persistent chest pain.

Principal Investigator

Dr Giovanni Luigi De Maria

Contact us

Email: oxfordheartresearch@ouh.nhs.uk

IRAS number

353498