iVascular has announced the first clinical outcomes of the Restorer bare metal stent (BMS) in iliac artery treatment.
The data were presented earlier this summer at the Leipzig Interventional Course (LINC 2024; 28–31 May, Leipzig, Germany) by Lieven Maene (OLV Hospital, Aalst, Belgium), principal investigator of the study. This presentation highlighted interim results from the BARISTA trial, a study evaluating the efficacy and safety of the Restorer in treating aortoiliac lesions.
A press release reports that the BARISTA trial has now successfully completed patient enrolment, involving a total of 200 participants. This is a prospective, multicentre, non-randomised, single-arm observational study designed to assess the long-term (24-month) safety and efficacy of Restorer in treating aortoiliac lesions, classified under TASC A, B, C, and D.
The interim analysis presented at LINC focuses on data from the first 67 patients with follow-up to 12 months. This first cohort included mainly TASC A and B lesions (86.6% combined) but 76.1% of all the lesions showed moderate to severe calcifications.
iVascular shares that Restorer demonstrates “outstanding” efficacy at 12 months in:
- Primary endpoint success: The study achieved primary patency of 96.9%, freedom from target lesion revascularisation (fTLR) of 98.5%, and 100% freedom from major amputation at 12 months.
- Ankle brachial index improvement: There was a significant mean increase of +0.24 in the ankle brachial index at 12 months compared to baseline.
Maene stated: “The interim results confirm the safety and efficacy of the Restorer stent in the treatment of iliac arteries, even with a high percentage of calcified lesions.”
He also highlighted Restorer’s benefits, such as its “excellent” trackability due to the low profiles (6Fr for all diameters) and flexibility to reach the lesion and achieve optimal wall apposition.
