MagicTouchâ„¢Sirolimus-Coated Balloon for Treatment of Coronary Artery Lesions in Small Vessels (NCT06271590) | Clinical Trial Compass
RecruitingNot Applicable
MagicTouchâ„¢Sirolimus-Coated Balloon for Treatment of Coronary Artery Lesions in Small Vessels
United States1,605 participantsStarted 2025-05-20
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Adult patient with an indication for PCI due to stable angina, NSTEACS, post-infarction angina or silent ischemia (in absence of symptoms a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, FFR ≤0.80, or non-hyperemic pressure ratio \[NHPR\] ≤0.89 must be present)
✓. Subject is ≥18 and \<80 years old
✓. Subject is willing to comply with all protocol-required follow-up evaluations and provides written informed consent
✓. Target reference vessel diameter (visual estimation) ≤2.75 mm
✓. Successful lesion preparation (residual stenosis \<30%), without flow-limiting complications (no or slow flow, dissection etc.)
✓. Target lesion(s) in a native coronary artery
✓. Up to two small vessel target lesions in two different vessels
✓. Target lesion length (visual estimation): ≥6.0 and ≤34.0 mm and can be covered by a single 40 mm balloon