Study of Drug-Coated Balloon Angioplasty for Treating Infrapopliteal Artery Lesions in Patients with Critical Limb Threatening Ischemia

What this Trial Is About

This research aims to assess the effectiveness and safety of drug-coated balloon DCB angioplasty for patients with critical limb-threatening ischemia CLTI who have significant artery blockages below the knee. It focuses on patients with severe limb ischemia classified as Rutherford category 4 to 6 and infrapopliteal arterial lesions suitable for angioplasty. The study is observational and conducted at multiple centers to gather real-world data on this treatment approach. Participants will be treated using the AcoArt drug-coated balloon to open blocked arteries below the knee. After the initial angioplasty procedure, follow-up visits will occur at 1, 3, 6, and 12 months. These visits will collect data on wound healing, ischemia, foot infections, artery calcifications, clinical improvements, and any need for further revascularization or adverse events related to the treated artery. During the study, participants will undergo evaluations including clinical assessments of limb status and questionnaires about vascular quality of life at multiple time points. Researchers will measure outcomes such as sustained clinical improvement, freedom from major limb adverse events, patency of the treated artery, and wound healing rates over one year. Safety and effectiveness will be monitored through these scheduled follow-ups, with total participation lasting up to 12 months after the procedure.

Durg Coated Balloon Angioplasty in Infrapopliteal Lesions