Clinical trial NCT05894863: Smart Flex Stent System for the Treatment Long Femoropopliteal Artery Lesions
Official title: Smart Flex Stent System for the Treatment Long Femoropopliteal Artery Lesions: the SAFARI Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: Femoropopliteal lesions
Patency
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Xuanwu Hospital, Beijing
name: Second Affiliated Hospital of Soochow University
name: First Affiliated Hospital of Zhejiang University
name: First People's Hospital of Hangzhou
name: Qingdao Haici Hospital
name: Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
name: Fudan University
name: Dongfang Hospital Beijing University of Chinese Medicine
name: Xiamen Cardiovascular Hospital, Xiamen University
First posted: 2023-06-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. The patient presented a score from 2 to 5 following Rutherford classification
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:

1. Previous bypass surgery or stenting in the target vessel
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

Primary outcomes:
measure: Primary patency
timeFrame: 12-month
measure: Freedom of major adverse events (MAEs)
timeFrame: 12-month
Secondary outcomes:
measure: Acute procedure success
timeFrame: 72-hour within procedure
measure: Primary patency
timeFrame: 24-month
measure: Freedom from clinically directed target lesion revascularization
timeFrame: 24-month
measure: Freedom of major adverse events (MAEs)
timeFrame: 24-month
measure: Primary sustained clinical improvement
timeFrame: 24-month
measure: Vasc quality of life score
timeFrame: 24-month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
state: Shanghai
Study officials:
affiliation: Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University
name: Meng Ye, M.D.
role: PRINCIPAL_INVESTIGATOR
References: