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

Abstract

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.

Pivotal Study of a Next-Generation Balloon-Expandable Stent-Graft for Treatment of Iliac Occlusive Disease

“…Iliac artery stenting has been largely successful, with good results over long-term follow-up, 24 particularly when stentgrafts have been used. 25 A recent first-in-human evaluation of the VBX Stent Graft reported a positive experience, 26 corroborated by the current study with 100% technical success, 97% acute procedure success, and a TLR rate of 2.3% at 9 months. Unlike other iliac stenting trials supporting FDA approval, this study was designed to reflect current practice.…”

A systematic review of covered balloon-expandable stents for treating aortoiliac occlusive disease

“…The most significant ABI improvement was reported by Bosiers et al, 26 with a mean ABI measurement of 0.59 at Journal of Vascular Surgery baseline, 0.98 immediately after stenting, and 0.99 at 12 months. The smallest ABI improvement was reported by Holden et al, 32 with mean ABI measurements of 0.79 at baseline and 0.95 at 12 months. Table VI.…”

“…All but one patient completed the 12-month follow-up in study reported by Holden et al 32 (no mean follow-up provided); similarly, Deloose et al 27 reported outcomes through 12 months (no further follow-up statistics provided). c All patients completed the 6-month follow-up in this study (no mean follow-up provided).…”

“…Among the 14 selected studies, eight were prospective and six were retrospective. Of the prospective studies, three were pilot/feasibility studies performed in Europe and Oceania 26,28,32 and five were safety/efficacy trials performed in Europe, Oceania, and the United States. 14,25,27,[34][35][36] Of the retrospective studies, all were about the Advanta V12/iCast, three were performed in the United States, 29,33,37 two were in Europe, 30,31 and one was in Oceania.…”

“…[22][23][24] A total of 15 publications (14 studies) were ultimately included in this review and underwent data extraction (Table I). 14,[25][26][27][28][29][30][31][32][33][34][35][36][37][38] The complete dataset comprised patients treated in both the prospective trial and retrospective, real-world settings. Clinical trial setting conformed to strict inclusion and exclusion criteria of the protocol.…”