Comparing Drug-Coated Balloons and New Generation Drug-Eluting Stents for Treating Bifurcation Coronary Artery Disease in Adults

What this Trial Is About

Researchers are evaluating different treatments for patients with bifurcation coronary artery disease affecting vessels larger than 2.0 mm in diameter. This international, multicenter, randomized clinical trial includes patients needing percutaneous coronary intervention PCI for stable coronary artery disease or acute coronary syndrome. The study compares two types of drug-coated balloons Paclitaxel and Sirolimus with new generation drug-eluting stents DES to assess their effects on bifurcation lesions. Participants will be randomly assigned to one of three groups Paclitaxel drug-coated balloons, Sirolimus drug-coated balloons, or standard treatment with new generation drug-eluting stents. After successful lesion preparation, the assigned device will be used following standard coronary angioplasty procedures. The study is open-label, meaning both patients and doctors know the treatment given. The research team follows international guidelines and local practices during the procedure. During the study, participants will have follow-up assessments including CT-FFR or invasive FFR at 6 to 9 months to measure artery narrowing at the treated bifurcation. Additional outcomes such as major adverse cardiac events, cardiac and all-cause death, myocardial infarction, vessel revascularization, thrombosis, and bleeding are monitored up to about 24 months. Patients will be evaluated regularly to track safety and the effectiveness of the treatments over time.

DCB vs. DES in Bifurcation Coronary Lesions