This study aims to evaluate the effectiveness and safety of the Smart flex stent system in treating long femoropopliteal native lesions.
One hundred twenty patients with lesion lengths longer than 15 cm will be included. Patients will be invited for a follow-up visit at 1, 6, 12, and 24-month post-procedure. The primary effectiveness endpoint of the study is the primary patency at 12 months. The primary safety endpoint is freedom of major adverse events (MAEs) at 12 months. Secondary endpoints include acute procedure success rate; primary patency rate at 1, 6, and 24 months; freedom from TLR at 1-, 6-, 12, and 24-month follow-up; primary and secondary sustained clinical improvements at 1-, 6-, 12- and 24-month follow-up; Freedom of MAEs at 1-, 6-,12- and 24- month follow-up; change of quality of life at 1-, 6-,12- and 24- month follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Smart flex stent will be used for femoropopliteal occlusive lesions.
Renji Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGPrimary patency
Primary patency is freedom from clinically directed target lesion revascularization (CD-TLR) and from Duplex ultrasound-derived binary restenosis (defined as peak systolic velocity ratio ≧2.5).
Time frame: 12-month
Freedom of major adverse events (MAEs)
Major adverse events(MAEs) is defined as index limb amputation above the ankle, clinically directed target lesion revascularization(CD-TLR), or all-cause death.
Time frame: 12-month
Acute procedure success
Acute procedure success is defined as technique success ( the achievement of final residual diameter stenosis \<30% for stent and \<50% for angioplasty or atherectomy by angiography at the end of the procedure and without flow-limiting arterial dissection or hemodynamically significant trans-lesional pressure gradient \<10 mm Hg for endovascular revascularization ) and freedom form major adverse events.
Time frame: 72-hour within procedure
Primary patency
Primary patency is freedom from clinically directed target lesion revascularization (CD-TLR) and from Duplex ultrasound-derived binary restenosis (defined as peak systolic velocity ratio ≧2.5).
Time frame: 24-month
Freedom from clinically directed target lesion revascularization
Patients without clinically directed target lesion revascularization
Time frame: 24-month
Freedom of major adverse events (MAEs)
Major adverse events(MAEs) is defined as index limb amputation above the ankle, clinically directed target lesion revascularization(CD-TLR), or all-cause death.
Time frame: 24-month
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Primary sustained clinical improvement
Primary sustained clinical improvement is defined as an upward shift on the Rutherford classification to a level of claudication without the need for repeated TLR in surviving patients without the need for unplanned amputation.
Time frame: 24-month
Vasc quality of life score
Change of Vasc quality of life
Time frame: 24-month