Abstract
Background: The Efemoral Vascular Scaffold System (EVSS) is a novel intravascular device consisting of a series of short, radially strong, balloon-expandable, sirolimus-eluting, bioresorbable scaffolds all mounted on a single delivery balloon and deployed via a single inflation.
Methods: The purpose of the multicenter First-in-Human EFEMORAL I clinical investigation is to evaluate the safety and performance of the EVSS in patients with symptomatic peripheral arterial occlusive disease.
Results: This abstract reports the clinical and imaging results of the first 20 patients enrolled in EFEMORAL I (mean age 74 years, 85% male). Patients presented commonly with severe claudication (60%) or ischemic rest pain (20%) with baseline ankle-brachial indices of 0.75±0.13. Most lesions were calcified (50%) and located within the mid- (30%) or distal superficial femoral artery (50%); mean lesion length was 5.1±2.0 cm and 40% were total occlusions. 6x60 mm (70%) and 6x80 mm (30%) EVSS were used for a total of 106 implanted scaffolds. The baseline minimal lumen diameter (MLD) of 0.65±0.77 mm increased to 2.91±0.76 mm following balloon angioplasty and to 5.02±0.84 mm after EVSS implantation (mean acute luminal gain of 4.37±1.09 mm). Post-procedure residual stenosis was 0%±15%. In a 6-month angiographic subgroup of 10 patients, MLD was preserved (4.75±0.86 mm with mean late lumen loss of 0.41±1.0 mm). After a median follow-up duration of 2-years (range 6-36 months), there were no instances of restenosis or target lesion revascularization (TLR). Device disappearance was confirmed on transcutaneous ultrasound after 2 years with maintained primary patency (100%). After 3 years, mean ABI remained elevated at 0.92±0.23 and walking improvement sustained (composite Walking Impairment Questionnaire score at baseline 52±22 vs. 92±17 after 3 years).
Conclusion: The EVSS is the first sirolimus-eluting bioresorbable scaffold designed for the percutaneous treatment of femoropopliteal occlusive disease. The radially rigid scaffolds optimized and maximized the post-procedure results, provided sustained antiproliferative drug elution, and completely dissolved between the first and second years after implantation.