Purpose: To report the outcome of the ACTIVE (Use of the Assurant Cobalt Iliac Stent System in the Treatment of Iliac Vessel Disease) study (ClinicalTrials.gov Identifier: NCT00753337), which was designed to determine the safety and effectiveness of the next-generation Assurant cobalt chromium balloon-expandable stent in symptomatic patients with iliac occlusive disease.
Methods: This prospective, multicenter, single-arm study enrolled 123 symptomatic (Fontaine class II or III) patients (69 men; mean age 65.5±10.6 years) with 159 de novo or restenotic lesions (length ≤100 mm) in the common or external iliac arteries. Objective measures of outcome were ankle or toe-brachial indexes, Fontaine class, and duplex ultrasound evaluations collected before the procedure and at 1 and 9 months. The primary endpoint of major adverse events (MAE) at 9 months was defined as device- and procedure-related death, target limb loss, or clinically-driven target lesion or target vessel revascularization (TLR/TVR).
Results: At 9 months, the rate of MAE was 0.8% with 1 TLR and 99.2% primary patency. There were no device- or procedure-related deaths or target limb amputations. The ankle-brachial index increased by 0.2±0.2 at 1 and 9 months. There was an improvement in the Fontaine classification of claudication for the majority of patients, accompanied by significant and sustained improvements in walking speed, distance, and stair climbing.
Conclusion: The balloon-expandable Assurant cobalt chromium iliac stent demonstrated an excellent safety profile and sustained patency associated with marked improvements in objective and functional measures of patency.