A Trail of Sperstent® Used for Residual Lesions of Femoropopliteal Arteries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorFrontAce Scientific Co., Ltd
About this trial
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
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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);
Trial design
Design model
Parallel
Treatments tested in this trial
Sperstent® peripheral spot stent system
DeviceSperstent® peripheral spot stent system, Percutaneous Transluminal Angioplasty (PTA), Digital Subtraction Angiography（DSA）
Everflex® self-expanding peripheral stent system
DeviceEverflex® self-expanding peripheral stent system, Percutaneous Transluminal Angioplasty (PTA), Digital Subtraction Angiography（DSA）
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: Sperstent® peripheral spot stent systemExperimental treatment 1 intervention
Group B: Everflex® self-expanding peripheral stent systemActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Primary Patency
Primary patency defined as freedom from clinically driven target lesion revascularization (CD-TLR) and freedom from duplex ultrasound derived binary restenosis at 12 months post-operation.(defined as PSVR \>2.5)
Time frame
12 months post-operation2
Freedom from Major Adverse Events (MAEs)
Freedom from the occurrence of any new-onset MAEs defined as all-cause death, index limb amputation (above the ankle), or clinically-driven target lesion revascularization (CD-TLR) at 30 days post-operation.
Time frame
30 days post-operationSecondary outcomes
1
Rate of Device Success
Defined as successful delivery, release and retrieval of the device.
Time frame
immediately post-operation2
Rate of Procedural Success
Demonstrated vessel patency (\<30% residual DS, by visual estimate) without the use of a bailout stent or the occurrence of MAE upon completion of the index procedure.
Time frame
immediately post-operation3
Primary Patency at 30 days and 6 months
defined as freedom from clinically driven target lesion revascularization (CD-TLR) and freedom from duplex ultrasound derived binary restenosis at 30 days and 6 months post-operation (defined as PSVR \>2.5)
Time frame
30 days and 6 months post-operation4
Rate of clinically driven target lesion revascularization (CD-TLR)
Clinically driven target lesion revascularization (CD-TLR) was defined as an endovascular reintervention performed for a \>50% diameter stenosis of the target vessel in the presence of a recurrent PAD symptom after the initial endovascular procedure.
Time frame
30 days, 6 months and 12 months post-operationSponsors and contacts
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Source ClinicalTrials.gov