iVascular recently announced the first patient enrolment 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.
BARISTA is a prospective, single-arm, multicentre, physician-initiated study led by Lieven Maene (Onze Lieve Vrouw Hospital, Aalst, Belgium) who enrolled the first two patients, achieving excellent flow rates after the implantation of the Restorer.
In total, 131 Belgian patients from 13 different hospitals will be included in this study with the purpose of assessing the long-term (up to 24 months) safety and efficacy of the Restorer in a controlled clinical setting on the treatment of complex TASC A, B, C and D aortoiliac lesions.
The primary endpoint of the study is freedom of any target lesion revascularisation (TLR), major amputation or restenosis (defined as significant stenosis on duplex ultrasound (>50%, systolic velocity ratio greater than 2.4) within 12 months. Secondary endpoints include technical success during procedure, and during the follow-up period: primary patency, stent occlusion rate, ankle brachial index (ABI), 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 one-month, six-month, 12-month and 24-month follow-up visits.
According to iVascular, the unique design of the Restorer CoCr stent provides excellent radial force with the minimum amount of metal to maintain the artery lumen and avoid restenosis. The company adds that the device is crimped on an Oceanus percutaneous transluminal angioplasty balloon, which offers outstanding navigability and profiles (6Fr introducer compatible for all diameters).
“Our centre has a huge experience using Restorer. 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,” Maene highlighted.