Healthcare products company Covidien has finished enrolling patients in its prospective, multinational, multicentre iliac stent clinical study series.
The studies, named VISIBILITY Iliac and DURABILITY Iliac, have enrolled 150 patients at 23 centres in the US and Europe to evaluate the safety and effectiveness of iliac stents in treating peripheral arterial disease (PAD) in the common iliac and external iliac arteries.
The VISIBILITY Iliac study will treat 75 patients using the 0.035 Visi-Pro balloon expandable stent system, which features radiopaque tantalum GPS markers on the distal and proximal ends of the stent to enhance visualisation both during and after stent placement.
The 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, which offer a robust size matrix and distinctive design to maintain vessel patency while minimising fractures, according to the company.
Covidien, which is expecting to follow study patients for a total of three years, said primary effectiveness of the stents and incidence of major adverse events will be evaluated over nine months.
Holy Name Medical Centre Interventional Institute medical director Dr 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 Dr Mark Turco said the results of the studies will enable physicians to make evidence-based decisions to allow for optimal patient outcomes.
"Covidien remains committed to bringing clinical data to the forefront, while working toward obtaining important disease and anatomic- specific labeling indications for our products," Turco said.