iCAST Balloon-Expandable Covered Stent for Iliac Artery Lesions: 3-Year Results from the iCARUS Multicenter Study

J Vasc Interv Radiol. 2019 Jun;30(6):822-829.e4. doi: 10.1016/j.jvir.2018.12.707. Epub 2019 Apr 25.

Abstract

Purpose: To evaluate safety and effectiveness of the iCAST Covered Stent for treatment of iliac artery atherosclerotic lesions.

Materials and methods: The iCARUS trial (ClinicalTrials.gov Identifier: NCT00593385) was a single-arm, prospective, multicenter study that enrolled 152 per protocol subjects at 25 sites in the United States and Germany. Subjects with multiple lesions and/or stents were eligible. The primary endpoint was the composite rate of death within 30 days, target lesion revascularization (TLR) within 9 months, or restenosis at 9 months after procedure. Secondary endpoints included major adverse vascular events (MAVEs), primary patency, freedom from TLR, and clinical success.

Results: Device and acute procedural success were achieved in 98.7% and 92.7% of cases, respectively. MAVE rate was 4.6% at 30 days. The 9-month primary composite endpoint rate was 8.1% (10/123), which was below the performance goal of 16.57%. Nine-month primary patency, defined as continuous flow without revascularization, bypass, or target limb amputation, was 96.4%. Freedom from TLR at 9 months and 3 years was 97.2% and 86.6%, respectively. Early clinical success was seen in 88.7% of subjects at 30 days with sustained clinical benefit in 72.4% of subjects at 3 years.

Conclusions: The iCARUS study demonstrated that the iCAST Covered Stent was safe and effective for treatment of atherosclerotic iliac artery lesions with sustained clinical benefit out to 3 years.

Publication types

  • Clinical Trial
  • Multicenter Study

MeSH terms

  • Aged
  • Amputation
  • Angioplasty, Balloon / adverse effects
  • Angioplasty, Balloon / instrumentation*
  • Angioplasty, Balloon / mortality
  • Female
  • Germany
  • Humans
  • Iliac Artery* / diagnostic imaging
  • Iliac Artery* / physiopathology
  • Limb Salvage
  • Male
  • Middle Aged
  • Peripheral Arterial Disease / diagnostic imaging
  • Peripheral Arterial Disease / mortality
  • Peripheral Arterial Disease / physiopathology
  • Peripheral Arterial Disease / therapy*
  • Progression-Free Survival
  • Prospective Studies
  • Prosthesis Design
  • Risk Factors
  • Stents*
  • Time Factors
  • United States
  • Vascular Patency

Associated data

  • ClinicalTrials.gov/NCT00593385