iVascular’s iCover Covered Stent to Be Evaluated in ILICO Study

May 3, 2022—iVascular announced the initiation of its first study with the company’s new-generation iCover covered stent, which received European CE Mark approval in March 2021. The ILICO study’s objective is to evaluate the safety and effectiveness of the iCover device for the treatment of de novo aortoiliac atherosclerotic lesions in patients with symptomatic arteriopathy of the lower limbs.

The first patient in the ILICO study was enrolled by Elias Noory, MD, who is Head, Interventional Angiology, Clinic for Cardiology and Angiology at the University Heart Center in Bad Krozingen, Germany. The case was transmitted live at the 2022 Charing Cross International Symposium, which was held April 26-28 in London, United Kingdom.

The patient had an occlusion in the right common and external iliac artery. The company noted that three iCovers were implanted successfully and achieved excellent flow. Additionally, the device demonstrated its visibility, conformability, and safety, which are expected to be confirmed in the ILICO study.

According to iVascular, ILICO is a prospective, multicenter, nonrandomized, single-arm observational study that will evaluate the efficacy and safety of the iCover covered stent for the treatment of de novo aortoiliac atherosclerotic lesions in 214 patients with symptomatic arteriopathy of the lower limbs at 18 sites in Germany, France, Belgium, and Spain.

Patients will be followed-up for up to 2 years. The primary endpoint of the study is primary patency at 12 months. Secondary endpoints include 30-day complications, major amputation at the target limb, target lesion revascularization, target vessel revascularization, and quality of life.

The ILICO study is led by Coprincipal Investigators Professor Thomas Zeller, MD, and Bahaa Nasr, MD. Prof. Zeller is Chief, Department Angiology, Clinic for Cardiology and Angiology at University Heart Center in Bad Krozingen, Germany. Dr. Nasr is Head of the Department of Vascular Surgery at CHU Brest, the University Hospital in Brest, France.

“We are excited and honored to participate in the trial and enroll the first patient of the ILICO trial,” commented Prof. Zeller in iVascular’s press release. “From our own experience, iCover facilitates the iliac arteries’ treatment with its radiopaque markers, flexibility, and excellent balloon crimping.”

Dr. Nasr added, “The start of ILICO study represents an exciting milestone, as iCover is an advancement of aortoiliac lesion treatment.”