iVascular has announced the presentation of the final one-year iliCo study results at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) annual congress (5–9 September, Copenhagen, Denmark). The data were presented by Bahaa Nasr (CHU Brest, Brest, France), co-principal investigator of the study.
iliCo is a prospective, multicentre, non-randomised, single-arm observational study evaluating the efficacy and safety of the iCover covered stent for the treatment of de novo iliac atherosclerotic lesions in patients with symptomatic arteriopathy of the lower limbs. Led by Bahaa Nasr and co-principal investigator Thomas Zeller (University Heart Center Bad Krozingen, Bad Krozingen, Germany), the study enrolled 232 patients across 18 sites in Germany, France, Belgium, and Spain, with follow-up planned for up to two years.
Its primary endpoint is primary patency at 12 months, while secondary endpoints include freedom from all major adverse events (MAE), major amputation of the target limb, target lesion revascularisation, target vessel revascularisation, and quality of life.
iliCo includes all types of iliac lesions, including the most complex ones: 30% of cases presented with TASC C and D lesions, 31% exhibited severe calcification and 31% were completely occluded.
iVascular reports that, as a result of iCover’s navigability and easy implantation, the technical success was 100%.
At one-year follow-up, the company reveals that iCover demonstrates “excellent” efficacy in iliac arteries, including complex lesions, achieving
- Freedom from target lesion revascularisation (fTLR): 96.7%
- Primary patency: 90.3%
These results were highlighted by Nasr, who emphasised the complexity of the treated lesions and the durability of the outcomes: “These results are highly encouraging, particularly given the complexity of the iliac lesions treated compared with other covered stent trials. Achieving 96.7% freedom from target lesion revascularisation and 93.6% freedom from restenosis demonstrates the strong and durable performance of iCover, supporting its role as an effective solution for challenging iliac interventions.”
