A Randomized Trial Comparing Drug-coated Balloon Angioplasty to Medical Therapy for Vulnerable Atherosclerotic Plaque in Acute Coronary Syndrome Patients

What this Trial Is About

Researchers are evaluating the use of drug-coated balloon DCB treatment compared to guideline-directed medical therapy GDMT in patients with acute coronary syndrome who have non-flow limited vulnerable plaques. The goal is to determine if DCB treatment is better at improving cardiovascular outcomes. This is a multicenter, prospective, open-label, controlled, randomized clinical trial sponsored by Harbin Medical University. Participants with vulnerable plaques that do not limit blood flow will be randomly assigned to either receive DCB treatment along with guideline-directed medical therapy or to receive guideline-directed medical therapy alone without intervention on the vulnerable plaques. The DCB treatment involves pretreatment of non-culprit lesions, with the possibility of using a bail-out stent if needed. Both groups will follow guideline-directed therapy throughout the study. During the study, participants will be monitored for clinical outcomes such as target lesion failure and major cardiac adverse events at multiple time points up to 24 months. Researchers will assess heart function and plaque characteristics at baseline and follow-up, including imaging and biomarker tests. The study is designed to follow participants for at least two years to evaluate the safety and effects of the treatments on heart health and plaque stability.

Preventive Drug-coated Balloon Angioplasty in Vulnerable Atherosclerotic Plaque (RESTORE Trial)