MagicTouch™Sirolimus-Coated Balloon for Treatment of Coronary Artery Lesions in Small Vessels
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorConcept Medical Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Planned (staged) intervention in the target vessel
ST-segment-elevation MI within 48 hours prior to index procedure
Subjects with acute cardiac decompensation or cardiogenic shock
Subject with a life expectancy of less than 24 months
Trial design
Treatments tested in this trial
- Sirolimus Drug Coated Balloon
- Drug eluting stents (DES)
Treatment groups
1,605 Participants
are divided into 2 treatment groupsSponsors and collaborators
Concept Medical Inc.
Lead sponsor
Cardiovascular Research Foundation, New York
Collaborator
Source ClinicalTrials.gov