Covidien has completed patient enrollment in its VISIBILITY and DURABILITY Iliac stent clinical study series.
The prospective, multinational, multicenter studies, which have enrolled 150 patients from 23 centers in the US and Europe, are designed to demonstrate the safety and effectiveness of iliac stents in treating peripheral arterial disease (PAD) in the common iliac and external iliac arteries.
Covidien said its VISIBILITY Iliac study will treat 75 patients using 0.035 Visi-Pro balloon expandable stent system and DURABILITY Iliac study will treat the remaining with either the EverFlex self-expanding stent system or the Protege GPS self-expanding nitinol stent and delivery technology,
In the study series, primary effectiveness of the stents and incidence of major adverse events will be evaluated through nine months.
The company is expecting to follow study patients for a total of three years.
Holy Name Medical Center Interventional Institute medical director John Rundback said, "The combined DURABILITY Iliac and VISIBILITY Iliac studies will provide a comprehensive evaluation of two complementary stent systems for the successful resolution of symptomatic aortoiliac obstructions."
Covidien vascular therapies chief medical officer Mark Turco said, "The results of the studies will enable physicians to make evidence-based decisions to allow for optimal patient outcomes."
