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

This is a multicenter, randomized, single-blind pivotal study to evaluate the safety and efficacy of the MagicTouchTM Drug coated balloon in treatment of small vessels in patients with coronary artery disease. The objective is to establish the safety and efficacy of the Magic TouchTM Drug coated balloon in treatment of small vessels (≤2.75 mm). A total of 1605 subjects will be enrolled in a maximum of 50 study sites located in North America. Additional sites located in Europe and South America may also participate in the study, with non-US sites contributing a maximum of \~50% of enrollees.

NCT Number	NCT06271590
Lead Sponsor	Concept Medical Inc. Collaborators: Cardiovascular Research Foundation, New York
Conditions	Coronary Artery Disease, Native Coronary Artery Stenosis, Cardiovascular Diseases
Enrollment	1,605 participants
Start Date	2025-05-20
Primary Completion	2028-11 (estimated)
Study Completion	2031-11 (estimated)
Updated on ClinicalTrials.gov	2025-09-11