Abstract
BACKGROUND: The study objective was to assess the postmarket safety and effectiveness of the GORE VIABHAN endoprosthesis with heparin bioactive surface for the treatment of in-stent restenosis (ISR) of the superficial femoral artery (SFA). METHODS: A prospective, single-arm, international study enrolled patients at 23 sites from October 2015 to April 2018. Patients with ≥50% ISR or occlusions in the SFA, Rutherford categories 2-5, and at least 1 patent runoff vessel were eligible. The primary effectiveness endpoint was primary patency at 12 months. The primary safety endpoint was the rate of device- or procedure related serious adverse events at 30 days. RESULTS: One hundred and eight patients were enrolled, and 86 were included for analysis through 3 years (mean age, 70.0 ± 10.4 years; 48.8% female). The mean core lab reported lesion length was 12.4 ± 6.92 cm (29.1% occlusions); 10.5% presented with chronic limb-threatening ischemia, and 81.9% of lesions were Tosaka II and II. Acute procedural success was 98.8%. Freedom from device- or procedure-related SAE was 96.5% through 30 days. At 1-year, primary, primary-assisted, and secondary patency rates were 74.7%, 80.4%, and 98.4%, respectively. Freedom from target lesion revascularization was 84.8%, 74.6%, and 65.0% at 1, 2, and 3 years, respectively. Per core laboratory assessment, no major amputations or device failures occurred through 3 years. At 3 years, 80.4% of patients had ≥ 1 Rutherford category improvement. CONCLUSIONS: The VIABAHN endoprosthesis is a safe and effective treatment for long and complex lesions in the SFA through 3 years.