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.
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.
Subject has symptomatic chronic limb-threatening ischemia, determined as Rutherford categories 4 or 5.
Subject is ≥ 18 years and ≤ 90 years of age.
Subject agrees to complete all protocol-required follow-up visits, including angiograms.
Subject with Body Mass Index (BMI) < 18.
Subject is pregnant or nursing. Subjects who plan pregnancy during the clinical investigation follow-up period may not be enrolled.
Estimated life expectancy <1 year, in the opinion of the Investigator at the time of enrollment.
Subject is permanently bedridden.
Single group
MAGNITUDE BRS
DeviceTreatment with the MAGNITUDE Scaffold
Primary Safety Endpoint: Freedom from MALE+POD (Major Adverse Limb Event + Peri-Operative Death)
Major Adverse Limb Event (MALE) includes above ankle amputation in index limb, major re-intervention on index limb at 6 months and Perioperative Death (POD) includes perioperative (30-day) mortality.
Primary Efficacy Endpoint: Composite of Limb Salvage and Primary Patency
Composite of Limb Salvage and Primary Patency includes freedom from: above ankle amputation in index limb, 100% total occlusion of target vessel, binary restenosis of target lesion and clinically-driven target lesion revascularization (CD-TLR).
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