Smart Flex Stent System for the Treatment Long Femoropopliteal Artery Lesions: the SAFARI Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peripheral Arterial Disease
- Sponsor
- RenJi Hospital
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Freedom of major adverse events (MAEs)
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
This study aims to evaluate the effectiveness and safety of the Smart flex stent system in treating long femoropopliteal native lesions.
Detailed Description
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Freedom of major adverse events (MAEs)
Time Frame: 12-month
Major adverse events(MAEs) is defined as index limb amputation above the ankle, clinically directed target lesion revascularization(CD-TLR), or all-cause death.
Primary patency
Time Frame: 12-month
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).
Secondary Outcomes
- Freedom from clinically directed target lesion revascularization(24-month)
- Acute procedure success(72-hour within procedure)
- Primary patency(24-month)
- Freedom of major adverse events (MAEs)(24-month)
- Primary sustained clinical improvement(24-month)
- Vasc quality of life score(24-month)