Post Market Follow-up Study of Acotec Drug-Coated Balloon Catheters for Lower Limb Artery Treatment in Patients with Peripheral Artery Disease

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the AcoArt drug-coated percutaneous transluminal angioplasty PTA balloon catheters in patients with symptomatic peripheral artery disease undergoing lower limb revascularization. This observational study includes patients with varying severity of arterial disease, classified by Rutherford Clinical Categories 2-6, to monitor real-world outcomes following standard treatment practices. Participants will receive treatment using one of three types of AcoArt drug-coated PTA balloon cathetersOrchid, Tulip, or Litosdesigned for arteries in the lower limbs. The study is a single-arm, multi-center follow-up that observes outcomes without altering usual care, focusing on two patient groups those with moderate symptoms Rutherford 2-3 and those with critical limb ischemia Rutherford 4-6. Throughout the study, participants will undergo various assessments to track safety and treatment effectiveness at multiple time points, including 30 days, 6 months, 12 months, and up to 60 months. Researchers will collect data on clinical improvements, wound healing, need for additional procedures, survival rates, and amputation rates. Patients are expected to attend follow-up visits and comply with study protocols for monitoring and data collection during this extended observation period.

Acotec DCB Post Market Clinical Follow-up