MagicTouch Sirolimus-coated Balloon for Treatment of In-Stent Restenosis in Coronary Artery Lesions
Concept Medical Inc.
Summary
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).
Description
All subjects providing informed consent will have their medical history reviewed and will undergo a physical examination, laboratory screen, and a standardized 12-lead ECG within 7 days of procedure. Women of childbearing potential will have a pregnancy test within one week prior to the procedure. If subjects meet the inclusion and exclusion criteria of the study, they will be randomized to one of two treatment groups, and will then undergo treatment with MagicTouch™ sirolimus-coated balloon or POBA of the target ISR lesion, per trial protocol. One pre-procedure and all post-procedure biomark…
Eligibility
- Age range
- 18–110 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Subject is at least 18 years old 2. Subject (or legal guardian) understands the trial requirements and treatment procedures and provides written informed consent prior to any trial-specific tests or treatment 3. Patient with an indication for PCI due to suspected in-stent restenosis 4. Non-target lesion PCI are allowed in non-target vessels to be treated with approved interventional devices prior to randomization as follows: Angiographic Inclusion Criteria: 1. In-stent restenosis after drug-eluting stent implantation(s) in the target lesion (i.e. single and multiple s…
Interventions
- DeviceSirolimus Drug Coated Balloon
Magic 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.
- DevicePlan balloon Angioplasty (POBA)
Plan balloon used to open clogged or narrow coronary arteries due to underlying atherosclerosis
Locations (28)
- Cardiology, PC - Princeton Baptist Medical CenterBirmingham, Alabama
- Dignity Health - Mercy Gilbert Medical CenterGilbert, Arizona
- Cedars - Sinai Medical CenterLos Angeles, California
- Yale University / Yale New Haven HospitalNew Haven, Connecticut
- Cheek-Powell Heart and Vascular PavilionClearwater, Florida
- Clearwater Cardiovascular and Interventional ConsultantsClearwater, Florida