iVascular has announced the initiation of its first trial with the new generation covered stent iCover—the iliCo study. The study 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 Elias Noory (University Heart Center Bad Krozingen, Germany) part of the team of the co-primary investigator of the study, Thomas Zeller (University Heart Center Bad Krozingen, Germany). The case was transmitted live at the 2022 Charing Cross (CX) Symposium in London, UK (26–28 April, London, UK).
The case presented by 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.
The iliCo study is a prospective, multicentre, non-randomised, single-arm observational study led by Co-investigators Zeller and Bahaa Nasr (CHU Brest, 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 revascularisation (TLR), target vessel revascularisation (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, iVascular said in a press release.
“We are excited and honoured to participate in the trial and enrol the first patient of the iliCo trial,” says Zeller. “From our own experience, iCover facilitates the iliac arteries treatment with its radiopaque markers, flexibility, and excellent balloon crimping.”
“The start of iliCo study represents an exciting milestone as iCover is an advancement of aorto-iliac lesions treatment,” adds Nasr.
The iliCo live case and all CX broadcast sessions can be watched on demand by registered viewers.