Evaluating the Safety and Effectiveness of the G-stream Drug-Eluting Stent for Treating Blockages in the Above-the-Knee Femoropopliteal Artery

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the G-stream drug-eluting peripheral arterial stent system in treating narrowing or blockages in the femoropopliteal artery, which includes the superficial femoral artery and proximal popliteal artery. This multicenter, randomized, controlled trial compares the stent system to a drug-eluting balloon catheter called AcoArt-Orchid. The study focuses on patients with peripheral artery disease, aiming to improve blood flow and reduce artery re-narrowing. Participants are randomly assigned to receive either the G-stream drug-eluting stent or the AcoArt-Orchid drug-coated balloon. The stent releases sirolimus to help prevent artery narrowing, and is available in various sizes to fit affected arteries. The balloon catheter uses a special coating to deliver paclitaxel to the vessel wall to enhance treatment. Both devices are designed for use in the superficial femoral and proximal popliteal arteries. The study compares the two devices to see which is more effective and safe. During the study, participants will be monitored for up to 12 months with regular follow-up visits to assess artery openness, device success, clinical outcomes, and any adverse events. Measurements include the percentage of participants maintaining artery openness at 12 months, rates of repeated procedures on the treated vessel, and complications such as thrombosis or amputations. Researchers will use imaging and clinical evaluations to track progress and safety over time. Participants must attend all required visits and comply with study procedures throughout the follow-up period.

Evaluating the Safety and Efficacy of the G-stream® Drug-Eluting Stent in the Above-the-Knee Femoropopliteal Artery