iVascular recently announced the first patient enrollments in the BARISTA study, a Belgian physician-initiated study to assess the efficacy and safety of the Restorer balloon expanding stent (iVascular) for the treatment of aorto-iliac lesions.
BARISTA is a prospective, single-arm, multicenter, physician-initiated study led by Dr. Lieven Maene (Vascular and Thoracic Surgeon at Onze Lieve Vrouw hospital in Aalst, Belgium) who enrolled the first two patients, achieving excellent flow rates after the implantation of Restorer, peripheral stent system (iVascular).
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 Restorer peripheral stent system in a controlled clinical setting on the treatment of complex TASC A, B, C and D aorto-iliac lesions.
The primary endpoint of the study is freedom of any target lesion revascularization (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 1-month, 6-month, 12-month and 24-month follow-up visits.
Restorer CoCr stent unique design provides excellent radial force with the minimum amount of metal to maintain the artery lumen and avoid restenosis. It’s crimped on an Oceanus PTA balloon, which offers outstanding navigability and profiles (6F introducer compatible for all diameters).
“Our center 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.” highlighted Dr. Lieven Maene.
