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

J Endovasc Ther. 2017 Oct;24(5):629-637. doi: 10.1177/1526602817720463. Epub 2017 Jul 12.

Abstract

Purpose: To evaluate the safety and efficacy of a next-generation balloon-expandable stent-graft for the treatment of arterial occlusive disease in patients with de novo or restenotic lesions in the common and/or external iliac arteries.

Methods: A prospective, multicenter, single-arm safety and efficacy study ( ClinicalTrials.gov identifier: NCT02080871) of the VBX Stent Graft for treatment of de novo or restenotic lesions in the iliac arteries was conducted under an Investigational Device Exemption at 26 US sites and 1 New Zealand center. The study eligibility criteria were established with the aim of enrolling more "real-world" patients compared with previous iliac stent studies supporting Food and Drug Administration approval. The study enrolled 134 patients (mean age 66±9.5 years; 79 men) with 213 iliac lesions. Three-quarters of the population (101, 75.4%) had Rutherford category 3 ischemia, and 43 (32.1%) patients presented with TASC II C/D lesions. The primary endpoint was a composite of device- or procedure-related death within 30 days, myocardial infarction within 30 days, target lesion revascularization (TLR) within 9 months, and amputation above the metatarsals in the treated leg within 9 months.

Results: In all, 234 devices were implanted in 213 lesions with 100% technical success; 57 (42.5%) patients received kissing stents at the aortic bifurcation. No devices exhibited a discernable change in length after final deployment as determined by independent core laboratory quantitative angiographic analysis. At 9 months, 3 (2.3%) of 132 patients (1 lost to follow-up, 1 unrelated death) experienced a major adverse event (3 TLRs) related to the primary endpoint. At 9 months, there were no device-related serious adverse events or unanticipated adverse device effects.

Conclusion: 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.

Keywords: aortoiliac occlusive disease; balloon-expandable stent; claudication; common iliac artery; external iliac artery; occlusion; peripheral artery disease; stenosis; stent-graft.

Publication types

  • Clinical Trial
  • Multicenter Study

MeSH terms

  • Aged
  • Angioplasty, Balloon / adverse effects
  • Angioplasty, Balloon / instrumentation*
  • Arterial Occlusive Diseases / diagnostic imaging
  • Arterial Occlusive Diseases / physiopathology
  • Arterial Occlusive Diseases / surgery*
  • Blood Vessel Prosthesis Implantation / adverse effects
  • Blood Vessel Prosthesis Implantation / instrumentation*
  • Blood Vessel Prosthesis*
  • Constriction, Pathologic
  • Female
  • Humans
  • Iliac Artery / diagnostic imaging
  • Iliac Artery / physiopathology
  • Iliac Artery / surgery*
  • Male
  • Middle Aged
  • New Zealand
  • Prospective Studies
  • Prosthesis Design
  • Stents*
  • Time Factors
  • Treatment Outcome
  • United States
  • Vascular Patency

Associated data

  • ClinicalTrials.gov/NCT02080871