iVascular has announced the initiation of its first trial with the new generation covered stent iCover: the iliCo Study. iliCo has the objective of evaluating the safety and effectiveness of iCover for the treatment of de novo aorto-iliac atherosclerotic lesions in patients with symptomatic arteriopathy of the lower limbs.
The first iliCo patient was enrolled by Dr. Elias Noory (Head Interventional Angiology, Clinic for Cardiology and Angiology, University Heart Center Bad Krozingen, Germany) part of the team of the coPI of the study, Prof. Thomas Zeller (Chief Department Angiology, Clinic for Cardiology and Angiology, University Heart Center Bad Krozingen, Germany). The case was transmitted live at Charing Cross Symposium on April 27th.
The case presented by Dr. Noory was a patient with an occlusion in the right common and external iliac artery. Three iCovers were implanted successfully, achieving an excellent flow after the procedure.
iliCo Study is a prospective, multicenter, non-randomized, single-arm observational study led by Co-PIs, Prof. Thomas Zeller and Dr. Bahaa Nasr (Head of Department of Vascular Surgery, CHU Brest, France). The study will evaluate the efficacy and the safety of the iVascular iCover covered stent for the treatment of de novo aorto-iliac atherosclerotic lesions in 214 patients with symptomatic arteriopathy of the lower limbs across 18 sites in Germany, France, Belgium, and Spain.
Patients will be followed up for up to two years. The primary endpoint of the study is primary patency at 12 months. Secondary endpoints include 30-day complications, major amputation at target limb, target lesion revascularization (TLR), target vessel revascularization (TVR) and quality of life.
iCover received the CE mark on March 2021 and has demonstrated in different cases and used its unique visibility, conformability and safety during the procedure. These excellent features are expected to be confirmed in iCover first trial, the iliCo study.
“We are excited and honored to participate in the trial and enroll the first patient of the iliCo trial,” said Prof. Zeller. “From our own experience, iCover facilitates the iliac arteries treatment with its radiopaque markers, flexibility and excellent balloon crimping” – Prof. Thomas Zeller.
“The start of iliCo study represents an exciting milestone as iCover is an advancement of aorto-iliac lesions treatment” – Dr. Bahaa Nasr.