Long-Term Study of Coronary Sinus Reducer Device for Patients with Chronic Severe Angina Not Treatable by Surgery or Percutaneous Procedures

What this Trial Is About

This research involves patients with chronic disabling refractory angina pectoris classified as Canadian Cardiovascular Society CCS classes 2-4. These patients have persistent angina despite receiving the maximum tolerated anti-angina medical therapy and are not suitable for percutaneous or surgical revascularization. The study aims to evaluate the long-term safety and effectiveness of the Coronary Sinus Reducer device in this group of patients through a single-center, single-arm registry. Participants undergo implantation of the Coronary Sinus Reducer, a balloon-expandable, hourglass-shaped scaffold that is placed percutaneously into the coronary sinus via the venous system. This device narrows the coronary sinus to delay blood outflow. After implantation, patients receive a follow-up visit one month later, then clinical assessments every six months over an observation period extending up to five years. During the study, participants will have initial evaluations including medical history, clinical assessment of angina severity by CCS class, Seattle Angina Questionnaire scores, a 6-minute walk test, and echocardiography. The main outcomes measured will be the reduction in angina symptoms one year after device implantation. Secondary outcomes include adverse events, changes in aerobic capacity and endurance, and improvement in quality of life. Clinical follow-up will continue for up to five years to monitor safety and efficacy.

Lower Silesia Sinus Reducer Registry