NCT05894863

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	Smart flex stent	Smart flex stent will be used for femoropopliteal occlusive lesions.

Timeline

• Start date: 2023-05-31
• Primary completion: 2026-01-02
• Completion: 2027-01-02
• First posted: 2023-06-08
• Last updated: 2023-06-08

Locations

1 site across 1 country: China