A Trail of Sperstent® Used for Residual Lesions of Femoropopliteal Arteries
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
FrontAce Scientific Co., Ltd
240 participants
Jun 4, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria10
- 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.
- 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 Criteria20
- 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.
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Interventions
Sperstent® peripheral spot stent system, Percutaneous Transluminal Angioplasty (PTA), Digital Subtraction Angiography（DSA）
Everflex® self-expanding peripheral stent system, Percutaneous Transluminal Angioplasty (PTA), Digital Subtraction Angiography（DSA）
Locations(12)
View Full Details on ClinicalTrials.gov
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NCT06539689