Actively Recruiting
Smart Flex Stent System for the Treatment Long Femoropopliteal Artery Lesions
Led by RenJi Hospital · Updated on 2023-06-08
120
Participants Needed
1
Research Sites
187 weeks
Total Duration
On this page
Sponsors
R
RenJi Hospital
Lead Sponsor
X
Xuanwu Hospital, Beijing
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study aims to evaluate the effectiveness and safety of the Smart flex stent system in treating long femoropopliteal native lesions.
CONDITIONS
Official Title
Smart Flex Stent System for the Treatment Long Femoropopliteal Artery Lesions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has a Rutherford classification score from 2 to 5
- Patient agrees to attend follow-up evaluations at 1, 6, 12, and 24 months
- Patient is older than 18 years
- Patient understands the procedure and provides written informed consent
- Patient has a life expectancy of at least 24 months
- Guidewire has successfully crossed the target lesion before enrollment
- Target lesion length is 150 mm or longer by angiographic estimation
- Patient has stenosis greater than 50% or occlusion in the femoropopliteal artery
- Angiographic evidence shows patent distal popliteal artery and at least one distal runoff to the foot
You will not qualify if you...
- Previous bypass surgery or stenting in the target vessel
- Presence of acute intraluminal thrombus at the target lesion
- Known allergy or contraindication to Nitinol-titanium, antiplatelet therapy, anticoagulants, or thrombolytics
- Pregnant women or females with potential for childbearing
- Use of thrombectomy, atherectomy, or laser devices during procedure
- Untreated inflow disease in ipsilateral pelvic arteries with more than 50% stenosis or occlusion
- Current participation in another investigational drug or device study without primary endpoint reached
- Significant kidney dysfunction with serum creatinine over 2.0 mg/dl
- Known allergy to contrast media
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Renji Hospital
Shanghai, Shanghai Municipality, China, 200127
Actively Recruiting
Research Team
N
Ni Qihong, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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