title: First-in-Human Experience With the Gore Balloon-Expandable Covered Endoprosthesis in Iliac Artery Occlusive Disease.
abstract: To report the first-in-human iliac artery experience of a new balloon-expandable covered endoprosthesis.
  
  
  
  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.
  
  
  
  The primary 30-day safety endpoint was 0%. Per-subject estimates of primary patency, freedom from target lesion revascularization, and freedom from target vessel revascularization were 100% at 1 and 6 months and 96.6% at 12 months. Estimates of assisted primary and secondary patency were both 100% at 12 months. Freedom from major adverse events at 12 months was 100%. Most patients experienced improvements in Rutherford category, ankle-brachial index, and functional status that were sustained to 12 months.
  
  
  
  This positive first-in-human experience with the Gore balloon-expandable covered endoprosthesis suggests this device will have an important role in the management of aortoiliac occlusive disease.
authors.affiliation: 1 Department of Interventional Radiology, Auckland Hospital, Auckland, New Zealand.
authors.forename: Andrew
authors.initials: A
authors.lastname: Holden
authors.affiliation: 1 Department of Interventional Radiology, Auckland Hospital, Auckland, New Zealand.
authors.forename: Stephen
authors.initials: S
authors.lastname: Merrilees
authors.affiliation: 1 Department of Interventional Radiology, Auckland Hospital, Auckland, New Zealand.
authors.forename: Brendan
authors.initials: B
authors.lastname: Buckley
authors.affiliation: 1 Department of Interventional Radiology, Auckland Hospital, Auckland, New Zealand.
authors.forename: Brigid
authors.initials: B
authors.lastname: Connor
authors.affiliation: 1 Department of Interventional Radiology, Auckland Hospital, Auckland, New Zealand.
authors.forename: Frances
authors.initials: F
authors.lastname: Colgan
authors.affiliation: 2 Department of Vascular Surgery, Auckland Hospital, Auckland, New Zealand.
authors.forename: Andrew
authors.initials: A
authors.lastname: Hill
mesh_terms: D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D055109:Ankle Brachial Index; D001807:Blood Vessel Prosthesis; D003251:Constriction, Pathologic; D005260:Female; D006801:Humans; D007083:Iliac Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D023821:Limb Salvage; D008297:Male; D008875:Middle Aged; D009520:New Zealand; D058729:Peripheral Arterial Disease / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D010690:Phlebography; D010865:Pilot Projects; D011446:Prospective Studies; D011474:Prosthesis Design; D020127:Recovery of Function; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D018616:Ultrasonography, Doppler, Duplex; D014654:Vascular Patency
keywords: balloon-expandable stent; covered stent; iliac artery; occlusive disease; patency; stent-graft