ChampioNIR® SFA Stent EFS Study

Summary

Participation Requirements

Description

Device Overview: The ChampioNIR® SFA Stent is composed of a Nitinol alloy structure with an elastomeric micro-fiber mesh and is designed specifically to be used in the peripheral vasculature. The stent is characterized by high flexibility, strong radial support and high resistance to fractures, as w...

Device Overview: The ChampioNIR® SFA Stent is composed of a Nitinol alloy structure with an elastomeric micro-fiber mesh and is designed specifically to be used in the peripheral vasculature. The stent is characterized by high flexibility, strong radial support and high resistance to fractures, as well as high deliverability and precise positioning. Objectives: To assess the safety and feasibility of delivery and implantation of ChampioNIR® SFA Stent. To assess the early and long term ability of the stent to maintain vessel patency. To assess the long term safety of the ChampioNIR® SFA Stent. This study is designed as an early feasibility, prospective, open label, single arm study. 30 patients with infra-inguinal peripheral arterial disease appropriate for treatment with a femoro-popliteal stent will be treated with ChampioNIR® SFA stent implantation. All enrolled patients will be followed up at 30 days and up to 36 months. The follow-up visits will include patency evaluation by duplex ultrasound. Primary efficacy endpoint: Primary patency of the target lesion at 6 months. Primary patency is defined as the absence of target lesion restenosis (defined by Duplex ultrasound (US) peak systolic velocity ratio (PSVR) >2.4) Primary safety endpoint: Composite rate of freedom from all-cause death, target vessel revascularization or any amputation of the index limb through 30 days following stent implantation. Secondary efficacy endpoints: Primary patency defined by Duplex US peak systolic velocity ratio (absence of restenosis which defined by Duplex US PSVR >2.4) at 30 days and 12 months. Acute device success, defined as achievement of a final residual diameter stenosis of <50% by Quantitative Angiography (QA), using the assigned treatment only. Acute procedural success, defined as device success with <50% residual stenosis immediately after stent placement or mean trans-stenotic pressure gradient <5 mmHg, and without the occurrence of death, amputation or repeat revascularization of the target lesion during the hospital stay. Acute technical success, defined as the attainment of <50% residual stenosis by QA by any percutaneous method as determined by the angiographic core laboratory. The following endpoints at 30 days 6, 12, 24 and 36 months: Secondary Patency (absence of restenosis which is defined as Duplex US PSVR ? 2.4) Change of Rutherford classification from baseline Change of resting ankle-brachial index (ABI) from baseline Change in walking impairment questionnaire from baseline Change in six minute walk test from baseline Secondary safety endpoints: Combined rate of death at 30 days, target lesion revascularization (TVR), index limb amputation and increase in Rutherford-Becker Classification by ?2 classes (as compared to post-procedural assessment) throughout 12 months. Stent fracture at 30 days 6, 12, 24 and 36 months. Stent fractures will be analyzed by a two-view X-ray evaluation by a designated core laboratory, compared with a baseline two-view X-ray taken before discharge and defined as type I, II, III, IV or V as follows: Type I - a single strut fracture only. Type II - multiple single nitinol stent fractures that can occur at different sites. Type III - multiple nitinol stent fractures resulting in complete transverse linear fracture but without stent displacement. Type IV - a complete transverse linear type III fracture with stent displacement. Type V - a spiral dissection of a stent. Freedom at 30 days from all-cause death, index limb amputation above the ankle and TVR. The following endpoints will be assessed at 30 days, 6, 12, 24 and 36 months: All-cause death Amputation (above the ankle)-Free Survival (AFS) Target Vessel Revascularization (TVR) Re-intervention for treatment of thrombosis of the target vessel or embolization to its distal vasculature Major Adverse Limb Events (MALE) at 30 days, 6, 12, 24 and 36 months: Stent thrombosis Clinically apparent distal embolization (defined as causing end-organ damage, e.g. lower extremity ulceration, tissue necrosis, or gangrene) Procedure-related arterial rupture Acute limb ischemia Target limb amputation Procedure related bleeding event requiring transfusion Sample Size and Statistical Analysis: The study is an early feasibility study and is not powered towards finding significant differences in the primary endpoints. The sample size of up to 30 patients will allow for the evaluation of feasibility and safety of the procedure, to support the initiation of a pivotal study. No formal statistical power calculations were conducted.

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