A Trail of Sperstent® Used for Residual Lesions of Femoropopliteal Arteries

Exclusion Criteria

• •Target vessel had undergone open surgery such as bypass surgery or the target lesion is in-stent restenosis;
• •Patients with serum creatinine \>2.5mg/dl during screening or undergoing long-term hemodialysis or peritoneal dialysis;
• •Severe coagulation disorder;
• •Patients with major vascular-related diseases, including acute lower extremity ischemia, active disseminated intravascular coagulation, thromboangiitis obliterans, deep vein thrombosis, and aneurysms of therapeutic lateral vessels (deep femur, superficial femur, or popliteal artery);
• •A history of major organ failure or other serious illness (including severe coronary heart disease, severe cardiac insufficiency, severe neurosis, or mental illness); Have received or plan organ transplantation, severe gastrointestinal bleeding);
• •Myocardial infarction or symptomatic stroke occurred within 3 months prior to enrollment;
• •Thrombolysis of target vessel within 72 hours before surgery, did not completely dissolve the thrombus;
• •Systemic infection or uncontrolled infection within the target limb;
• •Known allergy to contrast agents, nickel or titanium (Nitinol), heparin, aspirin, clopidogrel, anesthetics;
• •Women who are pregnant or breast-feeding, or women of childbearing age who have family plans within 1 year;
• •Patients who are planning to have major lower limb amputations on the target side of the lesion;
• •Endovascular or surgical procedures are performed on the target limb within 30 days before or 30 days after surgery;
• •Participating in clinical trials of other medical devices or drugs;
• •The investigator considers the patient is not suitable for participation in the clinical trial.
• •Failure of the guidewire to pass through the lesion；
• •During the procedure, the target lesions had received or were scheduled to receive volume reduction procedures such as cryogenic angioplasty, laser angioplasty, and percutaneous intracavity plaque gyrotomy；
• •The target lesion before stent implantation is thrombotic obliteration, which is not suitable for stent implantation；
• •The target lesions were severely calcified and could not fully predilate; Or grade 4 calcification；
• •Acute vascular occlusion or acute or subacute thrombosis in the target lesion；
• •Stent was implanted into the target vessel before enrollment.