A prospective randomized trial designed to compare the efficacy and safety of spot stent system versus self-expanding peripheral stent system in the endovascular treatment of femoropopliteal arterial stenotic disease.
The objective of this clinical investigation is to assess the efficacy and safety of spot stent system ,which is indicated for use in patients with atherosclerotic disease of the superficial femoral artery (SFA) or proximal popliteal arteries and for the treatment of insufficient results after percutaneous transluminal angioplasty.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
196
Spot stent system designed and produced by Acotec
Self-expanding peripheral stent system designed and produced by Ev3, Inc
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
RECRUITINGZhejiang Provincial People'S Hospital
Zhejiang, Zhejiang, China
RECRUITINGThe primary patency rate of target lesion at 12 months post-procedure
Defined as freedom from clinically driven target lesion revascularization (CD-TLR) and binary restenosis (restenosis defined as duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) ≥2.4)
Time frame: 12 months post-procedure
Rate of device success
Defined as successful delivery, release and retrieval of the device.
Time frame: immediate post-procedure
Rate of procedural success
Defined as no provisional stent implanted or major adverse event occured prior to discharge.
Time frame: 7 days post-procedure
Rate of clinically driven target lesion revascularization within 12 months post-procedure
Defined as any reintervention at the target lesion due to the following symptoms: drop of ABI \>20% or ABI \>0.15 compared to the post-procedure ABI
Time frame: 12 months post-procedure
The change of Rutherford class from baseline
Defined as change in target limb Rutherford class from baseline to 12 months
Time frame: 12 months post-procedure
The change of ankle-brachial index (ABI) from baseline
Defined as change of target limb ABI from baseline to 12 months
Time frame: 12 months post-procedure
Rate of composite safety endpoint
Defined a composite rate of all cause death, major target limb amputation (above-the-ankle amputation), clinically driven target lesion revascularization (CD-TLR) through 30 days post- procedure
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Time frame: 30 days post-procedure