Smart Flex Stent System for the Treatment Long Femoropopliteal Artery Lesions

Study Overview
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Brief Summary
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This study aims to evaluate the effectiveness and safety of the Smart flex stent system in treating long femoropopliteal native lesions.

Detailed Description
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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.

Official Title
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Smart Flex Stent System for the Treatment Long Femoropopliteal Artery Lesions: the SAFARI Study

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: Smart flex stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient presented a score from 2 to 5 following Rutherford classification The patient is willing to comply with specified follow-up evaluations at the specified times The patient is >18 years old Patient understands the nature of the procedure and provides written informed consent before enrolment in the study The patient has a projected life expectancy of at least 24 months Before enrolment, the guidewire has crossed the target lesion Target lesion length ≧150mm by angiographic estimation Stenosis > 50% or occlusion in the femoropopliteal artery There is angiographic evidence of patent distal popliteal artery and at least one distal runoff to the foot Exclusion Criteria: Previous bypass surgery or stenting in the target vessel Patients who exhibit acute intraluminal thrombus at the target lesion vessel Patients with known hypersensitivity or contraindication to any of the following medications: Nitinol-titanium, antiplatelet therapy, anticoagulants, or thrombolytics therapy Pregnant women or Female patients with potential childbearing Use of thrombectomy, atherectomy, or laser devices during the procedure Untreated inflow disease of the ipsilateral pelvic arteries (more than 50% stenosis or occlusion The patient is currently participating in another investigational drug or device study that has not reached the primary endpoint. Significant renal dysfunction (Serum creatinine >2.0mg/dl) Patient with Known allergy to contrast media

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smart flex stent group<br>Smart flex stent will be used for patients with femoropopliteal lesions receiving endovascular treatment. | Device: Smart flex stent<br>* Smart flex stent will be used for femoropopliteal occlusive lesions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 12-month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | 24-month | 
| Freedom from clinically directed target lesion revascularization | Patients without clinically directed target lesion revascularization | 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. | 24-month | 
| 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. | 24-month | 
| Vasc quality of life score | Change of Vasc quality of life | 24-month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Femoropopliteal lesions, Patency