BD completes iliac cohort enrollment in AGILITY study evaluating Revello stent for peripheral artery disease

Becton, Dickinson and Co., announced that it has completed full enrollment of the iliac artery patient cohort in its pivotal AGILITY Investigational Device Exemption study, which is evaluating the Revello Vascular Covered Stent in patients with peripheral arterial disease.

The milestone was shared during a late-breaking clinical trial presentation at the Vascular InterVentional Advances (VIVA) 2025 conference by Sean Lyden, chairman of the Department of Vascular Surgery at the Cleveland Clinic and global lead principal investigator for AGILITY.

"Achieving full enrollment of the iliac cohort marks a critical milestone for the AGILITY study and for patients living with peripheral arterial disease," Lyden said in a statement. "As our understanding of PAD deepens, the demand for innovative technologies that can expand our treatment options becomes increasingly critical."

The AGILITY study is a prospective, multi-center trial being conducted across up to 45 sites in the U.S., Europe, Australia, and New Zealand. It is designed to assess the safety and effectiveness of the Revello Vascular Covered Stent in treating de novo or restenotic lesions. The study includes two cohorts: a fully enrolled iliac artery group of 118 patients and a still-enrolling group of 223 patients with superficial femoral and proximal popliteal artery lesions.

“This milestone reinforces the commitment of BD to advancing clinically meaningful innovation in endovascular care,” said JD Meler, MD, FSIR, vice president of BD Enterprise Pre-Clinical Strategy and Medical Innovation. “The Revello Vascular Covered Stent is our next-generation system, designed to support physicians and help optimize outcomes for patients.”

Advances in peripheral artery disease treatment

Recent years have seen major progress in the treatment of peripheral arterial disease, a condition characterized by the narrowing or blockage of arteries that supply blood to the limbs. Advances have focused on improving long-term vessel patency, reducing restenosis, and providing less invasive alternatives to surgery for complex arterial lesions.

One major area of innovation involves next-generation covered stents and drug-eluting devices that combine mechanical support with localized drug delivery to inhibit tissue growth that can cause re-narrowing. These technologies are designed to be more flexible and conformable to the anatomy of the arteries, especially in areas subject to movement such as the femoral or popliteal regions.

Endovascular imaging techniques—such as intravascular ultrasound and optical coherence tomography—are also transforming how clinicians plan and perform interventions. By providing detailed visualization of vessel structure and plaque composition, these tools help guide precise device placement and improve patient outcomes.

In parallel, new hybrid approaches are being studied that integrate endovascular therapies with surgical techniques for patients with extensive or calcified disease. Additionally, research into bioresorbable scaffolds and next-generation polymer coatings aims to minimize long-term complications and maintain vessel flexibility after treatment.

Together, these developments are helping expand therapeutic options for patients with PAD, particularly those at high risk of limb loss or with limited surgical alternatives. The convergence of device innovation, imaging technology, and clinical research is steadily moving the field toward safer, more durable, and more personalized vascular care.