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

Trial details

Who runs it

FrontAce Scientific Co., Ltd

Trial code

NCT06539689

Record updated

6 August 2024

Original description

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.Read full original descriptionShow less

A Prospective, Multicenter and Randomized Controlled Trial to Evaluate the Efficacy and Safety of Sperstent® Peripheral Spot Stent System Used for the Residual Lesions After Percutaneous Transluminal Angioplasty of Femoropopliteal Arteries

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.

Inclusion: 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: Target vessel had undergone open surgery such as bypass surgery or the target lesion is in-stent restenosis; 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; 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; 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；; 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); Systemic infection or uncontrolled infection within the target limb; Known allergy to contrast agents, nickel or titanium (Nitinol), heparin, aspirin, clopidogrel, anesthetics; Failure of the guidewire to pass through the lesion；; Acute vascular occlusion or acute or subacute thrombosis in the target lesion；; Patients with serum creatinine >2.5mg/dl during screening or undergoing long-term hemodialysis or peritoneal dialysis; 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; The investigator considers the patient is not suitable for participation in the clinical trial; Angiographic Exclusion Criteria:; 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；; Stent was implanted into the target vessel before enrollment.

ClinicalTrials.gov NCT06539689