R3 Vascular Inc.
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.
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…
CLTI patients treated with MAGNITUDE BRS
CLTI patients treated with PTA
Arctuva estimate
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