Smart Flex Stent System for the Treatment Long Femoropopliteal Artery Lesions
NCT ID: NCT05894863
Last Updated: 2023-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2023-05-31
2027-01-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Smart flex stent group
Smart flex stent will be used for patients with femoropopliteal lesions receiving endovascular treatment.
Smart flex stent
Smart flex stent will be used for femoropopliteal occlusive lesions.
Interventions
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Smart flex stent
Smart flex stent will be used for femoropopliteal occlusive lesions.
Eligibility Criteria
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Inclusion Criteria
2. The patient is willing to comply with specified follow-up evaluations at the specified times
3. The patient is \>18 years old
4. Patient understands the nature of the procedure and provides written informed consent before enrolment in the study
5. The patient has a projected life expectancy of at least 24 months
6. Before enrolment, the guidewire has crossed the target lesion
7. Target lesion length ≧150mm by angiographic estimation
8. Stenosis \> 50% or occlusion in the femoropopliteal artery
9. There is angiographic evidence of patent distal popliteal artery and at least one distal runoff to the foot
Exclusion Criteria
2. Patients who exhibit acute intraluminal thrombus at the target lesion vessel
3. Patients with known hypersensitivity or contraindication to any of the following medications: Nitinol-titanium, antiplatelet therapy, anticoagulants, or thrombolytics therapy
4. Pregnant women or Female patients with potential childbearing
5. Use of thrombectomy, atherectomy, or laser devices during the procedure
6. Untreated inflow disease of the ipsilateral pelvic arteries (more than 50% stenosis or occlusion
7. The patient is currently participating in another investigational drug or device study that has not reached the primary endpoint.
8. Significant renal dysfunction (Serum creatinine \>2.0mg/dl)
9. Patient with Known allergy to contrast media
18 Years
ALL
No
Sponsors
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Xuanwu Hospital, Beijing
OTHER
Second Affiliated Hospital of Soochow University
OTHER
First Affiliated Hospital of Zhejiang University
OTHER
First People's Hospital of Hangzhou
OTHER
Qingdao Haici Hospital
OTHER
Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
OTHER
Fudan University
OTHER
Dongfang Hospital Beijing University of Chinese Medicine
OTHER
Xiamen Cardiovascular Hospital, Xiamen University
OTHER
RenJi Hospital
OTHER
Responsible Party
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Principal Investigators
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Meng Ye, M.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University
Locations
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Renji Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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The SAFARI Study
Identifier Type: -
Identifier Source: org_study_id
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