Study Evaluating Eluvia Drug-Eluting Stent for Treating Femoral-Popliteal Artery Narrowing or Blockage

What this Trial Is About

Researchers are conducting a multicenter, prospective observational study involving 400 patients who have peripheral arterial disease affecting the femoral-popliteal artery segment. The study focuses on patients who have been implanted with the Eluvia drug-eluting stent. The goal is to analyze various outcomes including the technical success of the stent placement, how well the treated artery remains open patency, improvements in patients quality of life, and the economic impact of using the Eluvia stent. Participants receive the Eluvia drug-eluting stent as part of their treatment for severe narrowing or blockage of the femoral-popliteal artery. The study does not involve additional experimental treatments but observes patients who have undergone this specific stent implantation. Each patient is followed for two years after their procedure to collect data on the stents performance and related health factors. During the two-year follow-up, researchers monitor changes in Rutherford classification which assesses the severity of peripheral arterial disease, the need for re-intervention on the treated lesion, and limb salvage rates. They also evaluate technical success one month after stent placement, target lesion patency, mortality rates, quality of life changes, wound healing progress, and the economic aspects of the treatment. This comprehensive monitoring helps understand the overall impact of the Eluvia stent on patients vascular health and lives.

Eluvia DES for the Patients with Femoropopliteal Artery Lesions.