Medtronic, Inc. (Medtronic), is planning to complete the trial named “The ACTIVE (Use of the Assurant Cobalt Iliac Stent System in the Treatment of Iliac Vessel Disease) Study Using the Medtronic Assurant Cobalt Iliac Balloon-Expandable Stent System” by December 2012. The trial is currently recruiting participants in US. The study evaluates the safety and efficacy of the Assurant Cobalt Iliac Stent System in the treatment of de novo and restenotic lesions in iliac arteries of patients with peripheral artery disease (PAD).
The non-randomized, open label, uncontrolled, single group assignment, study will collect 9 month safety and efficacy data on the Assurant Cobalt Iliac Stent for all patients enrolled into the study. The estimated enrollment is 123 subjects. The study Principal Investigators are Robert G Monar, MD from Michigan Vascular Research Center and William Gray, MD from NY Presbyterian Hospital.