Evaluation of the Revello Low-Profile, Self-Expanding Covered Vascular Stent in Iliac Lesions: Nine-Month Outcomes of the Prospective, Multicenter AGILITY Study

Background AGILITY is a prospective, multicenter, single-arm IDE study to evaluate the safety and effectiveness of Revello, a novel low profile self-expanding covered stent in patients with iliac artery lesions (NCT06111469). Methods The iliac cohort consisted of 120 iliac subjects across 28 international sites. The composite primary endpoint was defined as device and/or procedure-related death or myocardial infarction through 30 days, or clinically driven target lesion revascularization (CD-TLR), or target limb major amputation, or target lesion restenosis through 9 months and was evaluated against a performance goal (PG) of 19%. Secondary endpoints include technical and clinical success, freedom from CD-TLR, primary patency, and major adverse events (MAE). Results The iliac cohort had a mean age of 67.0 years, 40.8% of the patients were female. The study included lesions with varied anatomical characteristics, TASC A (50.0%), TASC B (24.2%), TASC C (13.3%) and D (12.5%), occlusions (29.4%), involvement of the external iliac artery (51.7%), and moderate-to-severe calcification (49.6%). The primary binary composite endpoint was 3/108 (2.8%; 95% CI, 0.6%-7.9%; one-sided P<0.0001 versus PG 19%). Acute lesion-, procedural-, technical- and sustained clinical success rates were 100.0%, 97.5%, 99.3% and 95.5%, respectively. At 9-months, freedom from CD-TLR and TVR were both 98.3%, while primary patency was 97.2% at 9-months. MAE occurred in 1.7% of patients. Conclusions In the AGILITY IDE iliac cohort, treatment with the Revello, a self-expanding covered stent, was associated with favorable safety and clinical outcomes through 9 months, including achievement of the pre-specified PG for the primary endpoint.