Study Evaluating Safety and Effectiveness of Acotec Drug-coated Balloon for Treating Blockages in Below-the-Knee Arteries

What this Trial Is About

Researchers are evaluating the safety and performance of the Acotec Litos & Tulip Drug-coated Balloon DEB catheters for treating lesions in below-the-knee arteries in people with Peripheral Artery Disease. This prospective, multi-center, single arm study aims to gather detailed data on how well this device works and its safety when used for this condition. Participants are adults aged 18 to 75 with specific artery blockage conditions affecting blood flow below the knee. Participants will receive treatment using the DEB catheter, either the AcoArt Tulip 0.018 or AcoArt Litos 0.014 model, to address stenosis or occlusions in below popliteal arteries. This single arm study means all participants receive the study device without comparison groups. The treatment targets significant artery narrowing or blockages to improve blood flow. The study does not mention placebo or alternative treatments. During the study, participants will be monitored through regular follow-up visits to evaluate the primary outcome of artery patency at 6 months. Secondary outcomes include major adverse event rate at 30 days, patency rates up to 60 months, rates of major limb amputation, mortality, vessel and lesion revascularization, ulcer healing, and distal embolization rates. Participants will undergo examinations and assessments specified by the protocol to track their response to the treatment and safety over time. The study is expected to continue until April 2027.

ACOART BTK RENEW：A Post Market Clinical Study