Short-term outcomes of the iCover balloon-expandable covered stent for iliac artery lesions

Purpose: To describe the short-term follow-up results of the recently introduced iCover balloon-expandable covered stents for iliac artery lesions.

Methods: All consecutive patients treated with iCover balloon-expandable covered stents between March 2022 and August 2023 were retrospectively reviewed. The primary endpoint was target lesion revascularization (TLR) at 6 months. Secondary endpoints included major adverse events, freedom from TLR throughout the follow-up period, primary and secondary patency, and clinical and technical success.

Results: In the study population of 40 adult patients (87.5% men, mean age: 63.5 ± 11 years), the mean follow-up period was 6.2 ± 2.8 months. A total of 98 stents of various sizes were implanted. The technical success rate was 100%. Freedom from TLR was 95.8% [95%, confidence interval (CI): 95%- 96.6%], the primary patency rate was 91.7% (95%, CI: 89.8%-93.6%), and the secondary patency rate was 95.8% (95%, CI: 95%-96.6%) at 6 months. The all-cause mortality rate was 5%.

Conclusion: These real-world data demonstrate a high technical and clinical success rate, a high 6-month primary patency rate, and a low requirement for TLR. These are promising indicators for the safety and efficacy of iCover stents.

Clinical significance: Balloon-expandable covered stents are frequently used in iliac artery atherosclerotic disease. This study shows that the short-term follow-up results of the new iCover stent are satisfactory, indicating its safety and efficacy.