MagicTouch for Treatment of In-Stent Restenosis in Coronary Artery Lesions
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-110
SponsorConcept Medical Inc.
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject is at least 18 years old
Subject (or legal guardian) understands the trial requirements and treatment procedures and provides written informed consent prior to any trial-specific tests or treatment
Patient with an indication for PCI due to suspected in-stent restenosis
In-stent restenosis after drug-eluting stent implantation(s) in the target lesion (i.e. single and multiple stent layer ISR cases are eligible)
Disqualifiers
STEMI within 72 hours of presentation to the first treating hospital, whether a transfer facility or the study hospital
NSTEACS in whom the biomarkers have not peaked
PCI within the 24 hours prior to the index procedure (not including PCI performed in non-target lesions during the index procedure)
Prior DCB treatment (coronary or off-label peripheral) of target lesion ISR
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.
Plan balloon Angioplasty (POBA)
DevicePlan balloon used to open clogged or narrow coronary arteries due to underlying atherosclerosis
Treatment groups
492 Participants
are divided into 2 treatment groupsGroup A: MagicTouch Sirolimus-Coated BalloonExperimental treatment 1 intervention
Group B: POBAActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
TLF (Target Lesion Failure)
The composite rate of cardiac death, target-vessel MI (Myocardial Infarction) or ischemia-driven TLR (Target Lesion Revascularization)
Time frame
12 monthsSecondary outcomes
1
MACE (Major adverse cardiovascular events)
composite of cardiovascular mortality, any MI (Myocardial Infarction), and ID-TLR (Ischemia-Driven Target Lesion Revascularization)
Time frame
30 days and 6, 12, 24, 36, 48, and 60 months2
TVF (Target vessel failure)
composite of cardiovascular mortality, ID-TVR (Ischemia-Driven Target Vessel Revascularization), and TV-MI (Target Vessel Myocardial Infarction)
Time frame
30 days and 6, 12, 24, 36, 48, and 60 months3
Any revascularization
any repeat PCI or CABG
Time frame
30 days and 6, 12, 24, 36, 48, and 60 months4
ID-TLR (Ischemia-Driven Target Lesion Revascularization)
Repeat revascularization of the target lesion due to recurrent ischemia
Time frame
30 days and 6, 12, 24, 36, 48, and 60 monthsOther outcomes
1
Angina as assessed by SAQ-7 (Seattle Angina Questionnaire)
Quality of Life Endpoint, Angina will be assessed at these specified timepoints and prior to any invasive procedure
Time frame
30 days, 6, 12, 24, 36, 48 and 60 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