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
Qualifiers
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
Treatments tested in this trial
- Sirolimus Drug Coated Balloon
- Plan balloon Angioplasty (POBA)
Treatment groups
492 Participants
are divided into 2 treatment groupsSponsors and collaborators
Concept Medical Inc.
Lead sponsor
Cardiovascular Research Foundation, New York
Collaborator
Source ClinicalTrials.gov