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

Inclusion Criteria:

• Age 18-85 years old, male or female;

• The target lesion is located in the superficial femoral artery or the proximalpopliteal artery;

• Peripheral arterial stenosis or occlusive disease with symptoms consistent with theRutherford classification 2 to 5;

• Estimated life expectancy >1 year;

• Subject has been informed of and understands the nature of the study and providessigned informed consent to participate in the study.

Angiographic Inclusion Criteria:

• Stenosis rate ≥70% under DSA by visual estimate, or 100% occluded lesion with atotal lesion length less than 150mm (by visual estimate);

• Reference vessel diameter is between 3 mm and 7.5 mm, 50mm≤Total cumulative lengthof target lesions≤250mm; (In the case of bilimb lesions, a single target lesion withone limb meeting the protocol criteria is selected by the investigator; More than 2cm between lesions are considered as 2 lesions);

• After PTA treatment by DCB, there exists residual lesions, such as the target lesionhas over 30% residual DS and/or presence of at least one post-PTA dissection (TypeA-F) (by visual estimate);

• Patients with unobstructed inflow tract or successfully treated, visual residualstenosis ≤50%;

• Angiography showed at least one outflow tract was unobstructed at the distal end (Stenosis degree ≤70% before intervention).

Exclusion Criteria:

• Target vessel had undergone open surgery such as bypass surgery or the target lesionis in-stent restenosis;

• Patients with serum creatinine >2.5mg/dl during screening or undergoing long-termhemodialysis or peritoneal dialysis;

• Severe coagulation disorder;

• Patients with major vascular-related diseases, including acute lower extremityischemia, 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 coronaryheart 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 toenrollment;

• Thrombolysis of target vessel within 72 hours before surgery, did not completelydissolve 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 havefamily plans within 1 year;

• Patients who are planning to have major lower limb amputations on the target side ofthe lesion;

• Endovascular or surgical procedures are performed on the target limb within 30 daysbefore 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 theclinical trial.

Angiographic Exclusion Criteria:

• Failure of the guidewire to pass through the lesion；

• During the procedure, the target lesions had received or were scheduled to receivevolume reduction procedures such as cryogenic angioplasty, laser angioplasty, andpercutaneous intracavity plaque gyrotomy；

• The target lesion before stent implantation is thrombotic obliteration, which is notsuitable for stent implantation；

• The target lesions were severely calcified and could not fully predilate; Or grade 4calcification；

• Acute vascular occlusion or acute or subacute thrombosis in the target lesion；

• Stent was implanted into the target vessel before enrollment.