A Prospective, Multicenter and Randomized Controlled Trial to Evaluate the Efficacy and Safety of a Spot Stent System Using in the Percutaneous Transluminal Angioplasty of Femoropopliteal Arteries.
A prospective randomized trial designed to compare the efficacy and safety of spot stent system versus self-expanding peripheral stent system in the endovascular treatment of femoropopliteal arterial stenotic disease.
• Age ≥18 years old and ≤80 years old
• Had lower extremity arterial occlusive diseases, and Rutherford classification is 2-5
• Target lesion is in the superficial femoral artery (SFA) and/or proximal popliteal artery (above the knee), located ≥1 cm below the common femoral artery (CFA) bifurcation to the distal segment of the proximal popliteal artery at the superior end of the patella.
• Target lesion had severe stenosis (stenosis degree ≥70%) or occlusion.
• Presence of at least one patent infrapopliteal vessel.
• The length of target lesion ≥10 cm.
• After predilation, the target lesion has \<30% residual stenosis and presence of at least one flow-limiting dissection (by visual estimate).
• Subject (or legal guardian) understands the study requirements and procedures and provides written Informed Consent before any study tests or procedures are performed.