a trail of sperstent® used for residual lesions of femoropopliteal arteries

Conditions: Peripheral Arterial Disease; Stenosis; Dissection

Summary: this is a prospective, multi-center, randomized trial designed to investigate the efficacy and safety of sperstent® peripheral spot stent system versus everflex® self-expanding peripheral stent system in the endovascular treatment of post-balloon angioplasty (post-pta) residual lesions including stenoses and/or dissections in femoral and proximal popliteal arteries.


Eligibility criteria:
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.

Keywords: peripheral arterial disease spot stent