Evaluating MagicTouch17 Sirolimus-Coated Balloon for Treating Small Vessel Coronary Artery Disease in Adults

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the MagicTouchTM Sirolimus-Coated Balloon in treating small blood vessels 2.75 mm or less in diameter in patients with coronary artery disease. This multicenter, randomized, single-blind study aims to compare this drug-coated balloon with drug-eluting stents in patients needing percutaneous coronary intervention PCI for lesions in small native coronary arteries. The trial plans to enroll about 1605 subjects across up to 50 sites in North America, with additional sites in Europe and South America. Participants will be randomly assigned in a 21 ratio to receive either the MagicTouchTM sirolimus-coated balloon or a drug-eluting stent approved by the FDA either Everolimus or Zotarolimus eluting stents. The treatment targets a single lesion in a major coronary artery or side branch, with lesion size limits between less than 2.75 mm and up to 34 mm in length. Lesion preparation must be successful prior to treatment. The study includes a detailed follow-up period assessing outcomes up to 60 months, focusing on safety and performance measures. During the study, participants will provide medical history and undergo physical exams, lab tests, and a 12-lead ECG within 7 days before the procedure. Women of childbearing potential will have pregnancy tests before treatment. Patient-reported angina symptoms will be tracked using the Seattle Angina Questionnaire at baseline, 30 days, 6 months, and 12 months, with further follow-up visits to monitor target lesion failure and other cardiovascular events for up to five years. The primary outcome is target lesion failure at 12 months after intervention.

MagicTouch™Sirolimus-Coated Balloon for Treatment of Coronary Artery Lesions in Small Vessels