Covidien announced the commencement of enrolment in the DURABILITY Iliac and VISIBILITY Iliac studies. Marc Bosiers, Dendermonde, Belgium, enrolled the initial patients in the DURABILITY Iliac study, and Patrick Peeters, Bonheiden, Belgium, enrolled the first patient in the VISIBILITY Iliac study.
The DURABILITY and VISIBILITY are prospective, multicentre, non-randomised studies designed to confirm the safety and effectiveness of Covidien’s stent systems for treating disease in the common and/or external iliac arteries. The DURABILITY Iliac study will evaluate the Protégé EverFlex self-expanding stent system and the Protégé GPS self-expanding nitinol stent and delivery technology. The VISIBILITY Iliac study will evaluate the Visi-Pro balloon-expandable stent system.
Seventy five patients will be enrolled at up to 20 sites in Europe and the United States for each study. Peter Faries, Mount Sinai School of Medicine, New York, USA, and John Rundback, Holy Name Medical Center, New York, USA, are the principal investigators.
“The DURABILITY Iliac and VISIBILITY Iliac studies are highly significant,” commented Faries. “These trials will evaluate the effectiveness of three outstanding stents used to treat iliac artery occlusive disease, providing additional evidence of peripheral stenting as a recognised standard in the treatment of iliac artery diseases.”
“They represent unique companion studies for patients with a diverse range of symptomatic iliac atherosclerotic disease. Often, complex patient anatomic patterns exist that may support preferential treatment with one stent system compared to another; the availability of data on these different and complementary stents in comparable patient populations will improve the ability to make confident and evidence-based treatment decisions when caring for these patients,” Rundback added.
The Visi-Pro, Protégé EverFlex, and Protégé GPS stents are available in the United States for the palliative treatment of malignant neoplasms in the biliary tree.