Results of a multicenter trial for the treatment of traumatic vascular injury with a covered stent

J Trauma. 2006 Jun;60(6):1189-95; discussion 1195-6. doi: 10.1097/01.ta.0000220372.85575.e2.


Background: The safety and efficacy of endovascular treatment of arterial trauma using the Wallgraft Endoprosthesis was evaluated in a subgroup analysis of a prospective, multicenter, nonrandomized registry trial with a historical control to surgical management. Endpoints were exclusion success at procedure and at 12-months, primary patency and freedom-from-bypass at 12-months, and major adverse events.

Methods: Sixty-two patients were treated for arterial trauma from October 1997 to June 2003. The anatomic locations of the injuries were: iliac (33), subclavian (18), and femoral (11) arteries. Indication for treatment was perforation/rupture (33), acute pseudoaneurysm (10), AV fistula (16), and dissection (3). Exclusion and patency were assessed using arteriography, duplex ultrasound, CT, or MRA at postprocedure and 12-months. Major adverse event and mortality rates were compared with surgical intervention of arterial trauma using literature based objective performance criteria.

Results: The Wallgraft Endoprosthesis achieved postprocedure exclusion in 58 of 62 cases (93.5%). One-year exclusion rates were 91.3% iliac, 90.0% subclavian, and 62.3% femoral. One-year primary patency rates were 76.4% iliac, 85.7% subclavian, and 85.7% femoral. Freedom-from-bypass was achieved in 74.3% iliac and 100% femoral and subclavian injuries. The most common adverse events were stenosis (4.8%) and occlusion (6.5% early, 1.6% late). There were no device- or procedure-related deaths. Analysis of the literature revealed the rates and severity of complications are less than those associated with surgical repair.

Conclusion: The Wallgraft Endoprosthesis for the treatment of traumatic arterial injuries offers a promising alternative to conventional operative repair with comparable patency and less major morbidity and mortality.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study

MeSH terms

  • Angioplasty* / adverse effects
  • Arteries / injuries*
  • Bayes Theorem
  • Blood Vessel Prosthesis Implantation / adverse effects
  • Blood Vessel Prosthesis Implantation / methods*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Polyesters
  • Prospective Studies
  • Safety
  • Stents* / adverse effects
  • Survival Analysis
  • Vascular Patency
  • Wounds, Penetrating / mortality
  • Wounds, Penetrating / surgery*


  • Polyesters