Evaluation of the MAGNITUDE® Bioresorbable Drug-Eluting Scaffold in the Treatment of Patients With Below the Knee Disease in Australia
Trial Parameters
Brief Summary
The objective of this prospective, multi-center, clinical investigation is to evaluate the MAGNITUDE BRS System for the planned treatment of narrowed infrapopliteal lesions. Up to 30 subjects will be enrolled at approximately 3 clinical sites in Australia.
Eligibility Criteria
7.1.1 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 Human Research 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, determined as Rutherford categories 4 or 5. 4. Subject is ≥ 18 years and ≤ 90 years of age. 5. Subject agrees to complete all protocol-required follow-up visits, including angiograms. 7.1.2 Angiographic Inclusion Criteria 6. Target lesion(s) in the infrapopliteal vessel(s) of the same limb located in any of the following vessels: tibioperoneal trunk (TPT), anterior tibial artery (ATA), posterior tibial arter