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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Sirolimus Drug Coated Balloon
DeviceMagic TouchTM (Concept Medical) is a semi-compliant sirolimus drug coated balloon (SCB) for PCI, based on a polymer-free and nanocarrier based drug delivery technology.
Drug eluting stents (DES)
DeviceFor subjects randomized to the control group (DES), the treating physician will choose an FDA cleared DES (ZES or EES) and follow lesion preparation and stent deployment according to the Instructions per use (IFU) and institutional practices.
Treatment groups
1,605 Participants
are divided into 2 treatment groupsGroup A: MagicTouch Sirolimus-Coated Balloon (SCB)Experimental treatment 1 intervention
Group B: Drug eluting stents (DES)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Target lesion failure (TLF)
the composite of cardiovascular mortality, target-vessel myocardial infarction (TV-MI) and ischemia driven target lesion revascularization
Time frame
within 12 monthsSecondary outcomes
1
Procedural success
defined as residual diameter stenosis \<30% (DS), no flow-limiting dissection and with post-procedure The thrombolysis in myocardial infarction (TIMI) 3 flow, without the need for bailout stenting
Time frame
at baseline, during the procedure2
Target lesion failure (TLF)
defined as the composite of cardiovascular mortality, target-vessel myocardial infarction (TVMI) and ischemia driven target lesion revascularization
Time frame
30 days and at 6, 12, 24, 36, 48, and 60 months3
Ischemia driven target vessel revascularization (ID-TVR)
Repeat revascularization of the target lesion due to recurrent ischemia
Time frame
30 days and at 6, 12, 24, 36, 48, and 60 months4
Target vessel revascularization (TVR)
Repeat revascularization of the target vessel
Time frame
30 days and at 6, 12, 24, 36, 48, and 60 monthsOther outcomes
1
Angina as assessed by SAQ-7 (Seattle Angina Questionnaire)
Angina will be assessed at these specified timepoints and prior to any invasive procedure -Last angina assessment prior to any repeat coronary angiogram will be considered and subsequent assessments will be censored
Time frame
Quality of Life Endpoint evaluated at 30 days, 6 months, and 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Concept Medical Inc.
Lead sponsor
Cardiovascular Research Foundation, New York
Collaborator
Source ClinicalTrials.gov