Smart Flex Stent System for the Treatment Long Femoropopliteal Artery Lesions

Peripheral Arterial Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05894863
• Other study ID #: The SAFARI Study
• Status: Recruiting
• Phase: N/A
• Start date: May 31, 2023
• Est. completion date: January 2, 2027

Study information

• Verified date: May 2023
• Source: RenJi Hospital
• Contact: Ni Qihong, M.D.
• Phone: +8615801900772
• Email: niqihong1989[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 2, 2027
• Est. primary completion date: January 2, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• Smart flex stent
Smart flex stent will be used for femoropopliteal occlusive lesions.

Locations

Country	Name	City	State
China	Renji Hospital	Shanghai	Shanghai

Sponsors (10)

Lead Sponsor

Collaborator

RenJi Hospital

Dongfang Hospital Beijing University of Chinese Medicine, First Affiliated Hospital of Zhejiang University, First People's Hospital of Hangzhou, Fudan University, Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology, Qingdao haici hospital, Second Affiliated Hospital of Soochow University, Xiamen Cardiovascular Hospital, Xiamen University, Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary patency	Primary patency is freedom from clinically directed target lesion revascularization (CD-TLR) and from Duplex ultrasound-derived binary restenosis (defined as peak systolic velocity ratio ?2.5).	12-month
Primary	Freedom of major adverse events (MAEs)	Major adverse events(MAEs) is defined as index limb amputation above the ankle, clinically directed target lesion revascularization(CD-TLR), or all-cause death.	12-month
Secondary	Acute procedure success	Acute procedure success is defined as technique success ( the achievement of final residual diameter stenosis <30% for stent and <50% for angioplasty or atherectomy by angiography at the end of the procedure and without flow-limiting arterial dissection or hemodynamically significant trans-lesional pressure gradient <10 mm Hg for endovascular revascularization ) and freedom form major adverse events.	72-hour within procedure
Secondary	Primary patency	Primary patency is freedom from clinically directed target lesion revascularization (CD-TLR) and from Duplex ultrasound-derived binary restenosis (defined as peak systolic velocity ratio ?2.5).	24-month
Secondary	Freedom from clinically directed target lesion revascularization	Patients without clinically directed target lesion revascularization	24-month
Secondary	Freedom of major adverse events (MAEs)	Major adverse events(MAEs) is defined as index limb amputation above the ankle, clinically directed target lesion revascularization(CD-TLR), or all-cause death.	24-month
Secondary	Primary sustained clinical improvement	Primary sustained clinical improvement is defined as an upward shift on the Rutherford classification to a level of claudication without the need for repeated TLR in surviving patients without the need for unplanned amputation.	24-month
Secondary	Vasc quality of life score	Change of Vasc quality of life	24-month