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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Percutaneous transluminal implantation of the RFS in the infrapopliteal lesion
Medical Universiteit Graz
Graz, Austria
RECRUITINGSafety: Freedom from Major Adverse Limb Event (MALE) + Perioperative Death (POD)
Safety: Freedom from Major Adverse Limb Event (MALE) + Perioperative Death (POD) * MALE includes: * Above ankle amputation in index limb or Any target lesion re-intervention at 30-day follow-up * POD includes: Mortality at 30 days follow-up
Time frame: 30 day follow-up
Performance: Number of patients with Technical Success
Technical success is defined as successful delivery and deployment of the RFS to the target lesion resulting in a final residual area stenosis of ≤50% as assessed on intravascular ultrasound (IVUS). * Successful delivery is defined as reaching the target lesion and successful withdrawal of the delivery catheter. * Successful deployment is determined by the achieved pressure (in atm) on the balloon combined with visual assessment of the balloon inflation on angiography. * ≤50% residual area stenosis is verified by independent Core Lab analysis of perioperative IVUS measurements. If IVUS is not available or insufficient, ≤30% final residual diameter stenosis at perioperative angiography will be used to assess Technical Success.
Time frame: perioperative
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