Registry Study Comparing Outcomes of Stent and Non-Stent Treatments for Peripheral Arterial Disease Tracking Patient Progress After Endovascular Procedures

What this Trial Is About

Researchers are conducting an observational study called XLPAD to evaluate the effectiveness and use of stent and non-stent therapies among patients with peripheral arterial disease PAD. This study aims to create a registry including data from procedures and clinical follow-ups, collecting information from patients treated since January 1, 2005, until 14,000 patients are enrolled. The study focuses on comparing outcomes like need for revascularization, surgical interventions, amputations, and safety events such as death, heart attack, stroke, and procedural complications over 12 months. Patients who receive endovascular interventions involving stents or percutaneous transluminal angioplasty PTA in specific leg arteries, including superficial femoral, popliteal, peroneal, anterior tibial, or posterior tibial arteries, will be included. The study collects detailed background, lesion, intervention, and outcome data into an online system called REDCAP. Follow-up data is gathered at 6 and 12 months after the procedure, but follow-up visits are based on usual clinical care and not mandated by the registry. Treatment decisions, including use of stents or other therapies, remain at the discretion of the care team. Participants contribute by allowing the collection of their medical records, procedural details, and follow-up information. Data collected include patient characteristics, lesion features, treatment details, and clinical outcomes like walking distance and ankle-brachial index changes. Researchers will review events and outcomes up to 12 months post-procedure to assess treatment effectiveness and safety. The registry poses minimal risk since it observes routine care without altering treatments. Total participation duration depends on clinical follow-up timing, typically up to one year after the initial intervention.

Multi-Center Registry for Peripheral Arterial Disease Interventions and Outcomes