Eilenburg

Researchers are evaluating the safety and effectiveness of the AcoArt drug-coated percutaneous transluminal angioplasty (PTA) balloon catheters in patients with symptomatic arterial disease affecting the lower limbs. This study includes patients with peripheral artery disease across a range of severity, classified by Rutherford Clinical Categories from 2 to 6, including both claudicants and those with critical limb ischemia. The study is a prospective, multi-center, single-arm post-market clinical follow-up to collect real-world data on these devices. Participants will be treated with one of three AcoArt drug-coated balloon catheters (Orchid, Tulip, or Litos), designed to open narrowed or blocked arteries in the iliac, superficial femoral, popliteal, or infra-popliteal regions. Treatments are performed according to current instructions for use and institutional standard practices. The study follows patients after treatment to continue monitoring the performance and safety of these devices in lower limb revascularization. During the study, patients will undergo protocol-specified examinations and follow-up visits to assess outcomes. Researchers will evaluate primary efficacy and safety endpoints at different time points depending on the severity group, including 30 days, 6 months, and 12 months after treatment. Data collected will include clinical assessments, monitoring for adverse events, and treatment success in improving blood flow and symptoms related to peripheral artery disease.