Belgian Study to Assess the Efficacy and Safety of the RESTORER Iliac Stent for Treatment of Aorto-iliac Lesions.

The BARISTA study tests the safety and efficacy of the Restorer stent from the company iVascular. This stent is a medical device that is already approved for use in Europe, to treat stenotic (narrowed) iliac arteries. 200 Belgian patients from 13 different hospitals will be included in this study. Patients will be medically monitored for 2 years from the day of the study procedure. The treatment of the stenotic iliac arteries will be according to the standard of care, using the Restorer stent. This endovascular treatment consists of introducing the necessary materials in the blood vessels by a puncture in the groin under general or local anaesthesia, after which a thin plastic tube will be inserted into the femoral artery through the puncture site, until the stenotic iliac artery is reached. Medical imaging is done by angiography. The stenotic/occluded section of the artery will first be dilated by inserting and inflating a balloon. Next, the Restorer stent will be placed and, if necessary, another balloon may be inserted and inflated to allow the stent to fit nicely to the vessel wall and optimise the result. As per standard of care, follow-up will be done in the hospital after 1, 6, 12, and 24 months. During these visits, an ultrasound scan of the treated artery will be taken to evaluate the patency of the blood vessel. Also, two short questionnaires will be completed asking about the quality of life and walking difficulties. The use of medication will be recorded. If adverse events are experienced, they will be reported.