Bioresorbable Sirolimus-Eluting Scaffold Treatment for Below the Knee Disease
R3 Vascular Inc.
Summary
The objective of this prospective, single-blinded, randomized controlled trial is to evaluate the safety and efficacy of the MAGNITUDE BRS System for the planned treatment of narrowed infrapopliteal lesions. Approximately 276 subjects will be randomized in a 1:1 ratio. The clinical investigation will be conducted at up to 60 clinical sites globally.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
General Inclusion Criteria 1. Subject (or their legally authorized representative) has provided written informed consent prior to any study-related procedure, using the form approved by the Institutional Review Board / Ethics Committee. 2. Subject agrees not to participate in any other investigational device or drug study for a period of at least 12 months following the index procedure. Note: Questionnaire-based studies, or other studies that are non-invasive and do not require investigational devices or medications are allowed. 3. Subject has symptomatic chronic limb-threatening ischemia…
Interventions
- DeviceMAGNITUDE Sirolimus-eluting Bioresorbable Scaffold
CLTI patients treated with MAGNITUDE BRS
- DevicePercutaneous Transluminal Angioplasty (PTA)
CLTI patients treated with PTA
Locations (3)
- NYU Langone HealthNew York, New York
- CUMC/NYPNew York, New York
- Staten Island University Hospital - Northwell HealthStaten Island, New York