Clinical Research Directory

Inclusion Criteria: * Age 18-85 years old, male or female; * The target lesion is located in the superficial femoral artery or the proximal popliteal artery; * Peripheral arterial stenosis or occlusive disease with symptoms consistent with the Rutherford classification 2 to 5; * Estimated life expectancy \>1 year; * Subject has been informed of and understands the nature of the study and provides signed informed consent to participate in the study. Angiographic Inclusion Criteria: * Stenosis rate ≥70% under DSA by visual estimate, or 100% occluded lesion with a total lesion length less than 150mm (by visual estimate); * Reference vessel diameter is between 3 mm and 7.5 mm, 50mm≤Total cumulative length of target lesions≤250mm; (In the case of bilimb lesions, a single target lesion with one 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 lesion has over 30% residual DS and/or presence of at least one post-PTA dissection (Type A-F) (by visual estimate); * Patients with unobstructed inflow tract or successfully treated, visual residual stenosis ≤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 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. Angiographic Exclusion Criteria: * 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.