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

Abstract

The next-generation balloon-expandable stent-graft demonstrated notable 9-month safety and efficacy in treating iliac occlusive disease in patients reflecting common clinical practice.

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

“…[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.…”

Use of the Gore Viabahn VBX balloon‐expandable endoprosthesis in the congenital heart disease population

“…The VBX FLEX trial evaluated the VBX stent in patients with atherosclerotic peripheral artery disease (PAD), specifically aortic‐iliac occlusive artery disease. Outcomes of the trial showed 100% technical success of stent implantation and no device‐related serious adverse events at 9‐month follow‐up . Success in the treatment of PAD has been corroborated by subsequent case reports, and treatment of arterial aneurysms and pseudoaneurysms has been documented .…”

“…In comparison, the premounted Atrium Advanta V12 covered stent (Atrium, Hudson, NH), currently unavailable in the United States, reaches larger postdilation diameters but also requires a 9–11 French introducer sheath . Both stents utilize open cell 316 L stainless steel struts, however, the VBX covered stent has demonstrated excellent radial strength in follow up studies, whereas stent collapse has been reported with the Atrium Advanta V12 stent . Both stents offer unique advantages in terms of flexibility compared with previous covered stent options, such as the Cheatham Platinum covered stent (NuMED, Hopkinton, NY), which has excellent utility in CHD patients utilizing a zig configured platinum‐iridium metal stent to maximize radial strength, but is limited by its larger profile and use in tortuous vasculature …”

“…9-month follow-up. 1 Success in the treatment of PAD has been corroborated by subsequent case reports, [2][3][4] and treatment of arterial aneurysms and pseudoaneurysms has been documented. 5 However, there have been no reports regarding the use of the VBX covered stent in congenital heart disease (CHD).…”

“…This allows for maximal flexibility while maintaining excellent radial strength. Additionally, a thin fluoropolymer/elastomer film covers the balloon delivery system to minimize slippage and ensure stent‐graft retention during tracking and inflation . The VBX FLEX trial evaluated the VBX stent in patients with atherosclerotic peripheral artery disease (PAD), specifically aortic‐iliac occlusive artery disease.…”