iVascular’s Restorer Stent Evaluated in Belgian BARISTA Study of Aortoiliac Lesion Treatment

July 27, 2022—iVascular announced the first patient enrollments in the BARISTA study, a Belgian physician-initiated study to assess the efficacy and safety of the company’s Restorer balloon-expanding stent for the treatment of aortoiliac lesions.

According to the company, BARISTA is a prospective, single-arm, multicenter, physician-initiated study. The study will be composed of 131 patients from 13 hospitals in Belgium, with the purpose of assessing the long-term (up to 24 months) safety and efficacy of the Restorer peripheral stent system in a controlled clinical setting for the treatment of complex TransAtlantic Inter-Society Consensus A, B, C, and D aortoiliac lesions.

The study’s primary endpoint is freedom from any target lesion revascularization (TLR), major amputation, or restenosis (defined as significant stenosis on duplex ultrasound [> 50%, systolic velocity ratio > 2.4]) within 12 months.

Secondary endpoints include procedural technical success, as well as follow-up primary patency, stent occlusion rate, ankle-brachial index, freedom from TLR, clinical success (improvement of Rutherford classification), change in walking impairment questionnaire, change in quality-of-life questionnaire, freedom from above-the-ankle target limb amputation, and mortality.

Patients will have 1-, 6-, 12-, and 24-month follow-up visits.

The study is led by Lieven Maene, MD, a vascular and thoracic surgeon at Onze Lieve Vrouw hospital in Aalst, Belgium. Dr. Maene enrolled the first two patients in the study and achieved excellent flow rates after implantation of the Restorer peripheral stent system.

“Our center has a huge experience using Restorer,” commented Dr. Maene in the company’s press release. “With the BARISTA study, we aim to confirm the excellent clinical results we had in the past in a scientific way and demonstrate the outstanding performance of the Restorer stent system.”

iVascular stated that the Restorer cobalt chromium stent is designed to provide radial force with the minimum amount of metal to maintain the artery lumen and avoid restenosis. It is crimped on an Oceanus percutaneous transluminal angioplasty balloon (iVascular) that allows navigability and profiles (6-F introducer compatible with all diameters).