Smart Flex Stent System for the Treatment Long Femoropopliteal Artery Lesions

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: Smart flex stent

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ni Qihong, M.D.; Phone Number: +8615801900772; Email: niqihong1989@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Recruiting
      • Renji Hospital
      • Contact: Ni Qihong, M.D.; Phone Number: +86 15801900772; Email: niqihong1989@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Smart flex stent group; Smart flex stent will be used for patients with femoropopliteal lesions receiving endovascular treatment.	Device: Smart flex stent; Smart flex stent will be used for femoropopliteal occlusive lesions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Freedom from clinically directed target lesion revascularization	Patients without clinically directed target lesion revascularization	24-month
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
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
Vasc quality of life score	Change of Vasc quality of life	24-month

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Collaborators: First People's Hospital of Hangzhou; Fudan University; Xuanwu Hospital, Beijing; First Affiliated Hospital of Zhejiang University; Second Affiliated Hospital of Soochow University; Qingdao Haici Hospital; Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology; Xiamen Cardiovascular Hospital, Xiamen University; Dongfang Hospital Beijing University of Chinese Medicine
• Investigators: Principal Investigator: Meng Ye, M.D., Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2023
• Primary Completion (Estimated): January 2, 2026
• Study Completion (Estimated): January 2, 2027

Study Registration Dates

• First Submitted: May 31, 2023
• First Submitted That Met QC Criteria: May 31, 2023
• First Posted (Actual): June 8, 2023

Study Record Updates

• Last Update Posted (Actual): June 8, 2023
• Last Update Submitted That Met QC Criteria: May 31, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Patency; Femoropopliteal lesions
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: The SAFARI Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No