Dr John R Laird, UC Davis Medical Center, presented an update on the ICARUS trial, which is analysing the iCast (Atrium Medical), a novel balloon expandable covered stent that has utility in a variety of clinical applications. Laird said that “the ICARUS trial will provide useful data on the role of this device for the primary treatment of iliac occlusive disease and potential advantages/disadvantages relative to balloon expandable and self-expanding bare metal stents.” The study has been designed to enroll 25 sites and 225 patients (35 of them with total occlusions). Clinical follow-up will be assessed at 30 days, six, nine and 12 months, and includes a long-term annual follow-up through 36 months. The primary endpoint is a composite of death within 30 days, target site revascularisation or restenosis (by ultrasound) within nine months post-procedure. At 31 December 2008, 53 patients (77 limbs, 85 lesions, nine kissing stents and five total occlusions) had been enrolled.
