City of Orange

Researchers are evaluating the safety and effectiveness of the AcoArt Litos Paclitaxel Coated Balloon PCB catheter compared to a standard non-coated PTA balloon catheter in treating blockages in the infrapopliteal arteries of patients with chronic limb-threatening ischemia CLTI, specifically Rutherford category 4 or 5. The study aims to determine if the AcoArt Litos PCB offers better treatment outcomes while maintaining similar safety to the control device. This randomized controlled trial involves patients with critical blood flow issues in the lower leg arteries affecting limb health. Participants will be randomly assigned to receive either the PCB catheter experimental group or the standard PTA balloon catheter control group to treat narrowing or blockages in arteries below the knee but above the ankle joint. The devices are used during angioplasty procedures targeting vessels with specific size and lesion length criteria. The study includes a comprehensive evaluation of treatment success, safety events within 30 days, and longer-term vessel openness and limb outcomes over several years. During the trial, participants will undergo follow-up visits at multiple time points up to five years to assess limb health, vessel patency, wound healing, and adverse events. Researchers will measure outcomes such as major amputation-free survival, re-narrowing rates, and changes in blood flow indexes. Safety monitoring includes tracking major adverse limb events and peri-operative deaths shortly after treatment. Participants are expected to comply with scheduled visits and evaluations to provide detailed data on the treatments impact and durability.