First-in-Human Experience With the Gore Balloon-Expandable Covered Endoprosthesis in Iliac Artery Occlusive Disease.

Purpose: To report the first-in-human iliac artery experience of a new balloon-expandable covered endoprosthesis. Methods: A prospective, single-center pilot study recruited 30 symptomatic patients (mean age 64 years; 18 men) to evaluate the safety and early efficacy of the new Gore balloon-expandable covered endoprosthesis for the treatment of de novo or restenotic common and/or external iliac artery lesions. According to protocol, up to 2 discrete lesions could be treated with a maximum total treated length ≤110 mm. Follow-up included clinical evaluation with duplex ultrasound at 1, 6, and 12 months. Data are presented through 12-month follow-up. The primary safety endpoint was a composite of device- or procedure-related death, myocardial infarction, or amputation in the treated leg within 30 days of the index procedure. Multiple performance outcomes were also evaluated. Results: The primary 30-day safety endpoint was 0%. Per-subject estimates of primary patency, freedom from target lesion revasculariza...