Covered Stent System Achieves High Nine-Month Patency in Iliac Artery Disease

Iliac artery disease, a common form of peripheral artery disease, can restrict blood flow to the legs and impair mobility and quality of life. Clinicians continue to seek durable endovascular treatments that maintain vessel patency and reduce repeat interventions, particularly in complex iliac anatomy. A new covered stent system has now shown favorable nine-month safety, effectiveness, and functional outcomes in these patients.

BD (Becton, Dickinson and Company) announced positive nine-month results from the iliac cohort of the AGILITY Investigational Device Exemption trial evaluating the Revello Vascular Covered Stent. The device combines the flexibility of a nitinol self-expanding stent with radial resistive force designed for the iliac arteries. The ongoing study includes 36 months of follow-up to further assess long-term safety and performance.

The iliac cohort enrolled 120 patients across 28 investigational sites in the United States, Europe, Australia, and New Zealand. At nine months, the study met its primary composite endpoint, with a 2.8% failure rate compared with the prespecified performance goal of 19%. Primary patency was 97.2%, while freedom from clinically driven target lesion revascularization reached 98.3%. No device- or procedure-related deaths, target limb major amputations, or unanticipated serious adverse device effects were reported.

Functional outcomes also improved over the follow-up period. Mean Rutherford category decreased from 3.0 at baseline to 0.3, while the mean Walking Impairment Questionnaire score increased by 31.7 points. Women represented approximately 41% of participants, and slightly more than half of treated lesions had moderate-to-severe calcification.

The Revello Vascular Covered Stent is CE marked. In the United States, it remains an investigational device limited by federal law to investigational use. Enrollment in the study’s superficial femoral and proximal popliteal artery cohort was completed in August, while follow-up in the iliac cohort will continue through 36 months.

“These latest data showed high primary patency and low clinically driven target lesion revascularization in a patient population that included both straightforward and complex iliac lesions. Results showed the treated arteries remained open in a high percentage of patients, and at nine months, patients also showed changes in disease severity and walking ability,” said Sean Lyden, M.D., chairman of the Department of Vascular Surgery at Cleveland Clinic and global lead principal investigator for AGILITY.

“These results reflect the continued commitment of BD to advance evidence‑based innovation in peripheral vascular care. As follow‑up continues, the AGILITY study will help further characterize the Revello Vascular Covered Stent’s performance across patients with peripheral artery disease,” said Rob Righi, vice president and general manager of the Vascular Platform, Peripheral Intervention at BD.