RecruitingNot ApplicableNCT05894863

Smart Flex Stent System for the Treatment Long Femoropopliteal Artery Lesions

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

Sponsor

RenJi Hospital

Enrollment

120 participants

Start Date

May 31, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

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

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