Smart Flex Stent System for the Treatment Long Femoropopliteal Artery Lesions
Key facts
- Where
- Shanghai, ChinaSee the site
Where in China
- RenJi HospitalShanghai, ChinaContact: Ni Qihong, M.D.Taking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- RenJi Hospital
- Trial code
- NCT05894863
- Record updated
- 8 June 2023
- Original description
This study aims to evaluate the effectiveness and safety of the Smart flex stent system in treating long femoropopliteal native lesions.Read full original descriptionShow less
Smart Flex Stent System for the Treatment Long Femoropopliteal Artery Lesions: the SAFARI Study
This study aims to evaluate the effectiveness and safety of the Smart flex stent system in treating long femoropopliteal native lesions.
Inclusion: 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: Previous bypass surgery or stenting in the target vessel; The patient is currently participating in another investigational drug or device study that has not reached the primary endpoint; Patients with known hypersensitivity or contraindication to any of the following medications: Nitinol-titanium, antiplatelet therapy, anticoagulants, or thrombolytics therapy; Untreated inflow disease of the ipsilateral pelvic arteries (more than 50% stenosis or occlusion; Patient with Known allergy to contrast media; Significant renal dysfunction (Serum creatinine >2.0mg/dl); Patients who exhibit acute intraluminal thrombus at the target lesion vessel; Pregnant women or Female patients with potential childbearing; Use of thrombectomy, atherectomy, or laser devices during the procedure.