Initial Feasibility Study of the STENTiT Resorbable Fibrillated Scaffold (RFS). The RFS is Intended to Restore Lumen Patency and Blood Flow to Infrapopliteal Arteries. The RFS is a Fully Electrospun Tubular Device With a Fibrillated Microarchitecture and Designed for Transcatheter Delivery

This is the First-In-Human feasibility study of the RFS for below the knee lesions in subjects who experience critical limb ischemia due to the peripheral artery disease. The aim of this study is to investigate if the RFS can be implanted safely and with technical success. Up to 10 subjects will be treated with the RFS at one investigational site. Lesions within the inflow trajectory or side branches may be treated with institutions standard of care prior to treatment of the target lesion. This may include usage of POBA, BMS, DCB, or DES. The target lesion will be predilated with POBA. Device safety will be assessed throughout the clinical investigation, with primary safety endpoints defined as freedom from Major Adverse Limb Events (MALE) at 30 days follow-up. In addition, MALE at 3-, 6-, 12-, and 24- months follow-up, all adverse events, serious adverse events and all device deficiencies will be captured as secondary endpoints. Device performance will be based on technical success of the implantation defined as successful delivery and deployment with a residual area stenosis of ≤50% as determined on final perioperative IVUS. Primary patency at day of discharge, 30-days, 3-, 6-, 12-, and 24- months follow up will be captured as secondary performance endpoint and are based on duplex ultrasound for all timepoints and angiography and IVUS at 6-months follow-up.