Clinical Trial

MagicTouch for Treatment of In-Stent Restenosis in Coronary Artery Lesions

Study acronym: MAGICAL ISR
Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated February 25, 2025 (before its estimated September 2025 completion). Its status may not reflect the trial's current state.
Summary
A Prospective, Multicenter, Randomized, Two-Arm, Single-blind Superiority Trial to Evaluate the Safety and Efficacy of the MagicTouch™ Sirolimus- Coated Balloon in the Treatment of Coronary Drug-Eluting Stent In-Stent Restenosis. Subjects with prior DES implantation presenting with ISR lesions undergoing PCI will be randomized into two groups: treatment with the MagicTouch™ sirolimus-coated balloon or POBA on a 2:1 basis. Approximately 492 subjects will be enrolled in the randomized study in a maximum of 50 study sites located in the United States. The goal is to establish the safety and efficacy of the MagicTouch™ sirolimus- coated balloon in treatment of coronary in-stent restenosis (ISR).
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2023-06-09; most recent amendment 2025-02-24.
Status change: Not Yet Recruiting → Recruiting 2024-04-28
Status change: Withheld → Not Yet Recruiting 2023-08-02
Trial Details
NCT Number NCT05908331
Lead Sponsor Concept Medical Inc.
Collaborators: Cardiovascular Research Foundation, New York
Conditions In-Stent Restenosis, Cardiovascular Diseases, Coronary Artery Disease
Enrollment 492 participants
Start Date 2024-04-16
Primary Completion 2025-09 (estimated)
Study Completion 2028-07 (estimated)
Updated on ClinicalTrials.gov 2025-02-25