Vilvoorde

Researchers are evaluating the safety and effectiveness of the Supera Vascular Mimetic Implant, a special stent designed to treat narrowed or blocked areas in the common femoral artery, compared to traditional surgical removal of artery plaque (endarterectomy). This study focuses on patients with Peripheral Arterial Disease classified as Rutherford category 2, 3, or 4. The goal is to see if the implant is at least as effective as surgery and possibly safer for patients. Participants are randomly assigned to one of two groups: one receiving the Supera stent through a minimally invasive procedure involving balloon dilation and stent placement, and the other undergoing standard surgical endarterectomy. The procedure involves crossing the lesion with a guidewire, angiographic assessment, and optional post-dilation for the stent group. The surgery group receives treatment according to standard care. Follow-up visits are scheduled at 1, 6, 12, 24, and 36 months after the procedure. Throughout the study, patients will undergo assessments including physical exams, walking ability questionnaires, blood tests, ankle and toe blood pressure measurements, and ultrasound imaging to check blood flow. Researchers will monitor for outcomes such as artery openness (patency), need for additional treatments, wound healing, and any adverse events up to 36 months. Primary outcomes focus on artery openness at 12 months and safety within 30 days post-procedure.

Researchers are collecting data on patients with peripheral arterial occlusive disease (PAOD) who will be treated with the VITUS peripheral drug-coated dilatation catheter. This study aims to monitor the long-term safety and effectiveness of this device when used as part of routine clinical care. The study includes approximately 284 patients from around 15 centers in Europe, focusing on those undergoing percutaneous transluminal angioplasty (PTA) with this specific catheter. Participants receive treatment with a paclitaxel drug-coated balloon during angioplasty to address symptomatic peripheral arterial disease. Treatments follow the Instructions for Use and physician decisions. The treated lesion should be shorter than the nominal balloon length, but multiple overlapping balloons can be used for longer lesions to ensure full coverage. The registry records data over three years, with follow-ups immediately after the procedure, then at 30 days, 6 months, 12 months, 24 months, and 36 months. During the study, patients will have follow-up visits either by phone or in person to assess their health and treatment outcomes. Researchers monitor major adverse events at 30 days and 12 months after the procedure, as well as the occurrence of clinically driven target lesion revascularization at 12 months. The study ends when all patients complete the 36-month follow-up period, providing valuable information on the device's safety and performance in everyday clinical settings.