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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• The patient presented a score from 2 to 5 following Rutherford classification

• The patient is willing to comply with specified follow-up evaluations at the specified times

• The patient is \>18 years old

• Patient understands the nature of the procedure and provides written informed consent before enrolment in the study

• The patient has a projected life expectancy of at least 24 months

• Before enrolment, the guidewire has crossed the target lesion

• Target lesion length ≧150mm by angiographic estimation

• Stenosis \> 50% or occlusion in the femoropopliteal artery

• There is angiographic evidence of patent distal popliteal artery and at least one distal runoff to the foot

Locations
Other Locations
China
Renji Hospital
RECRUITING
Shanghai
Contact Information
Primary
Ni Qihong, M.D.
niqihong1989@163.com
+8615801900772
Time Frame
Start Date: 2023-05-31
Estimated Completion Date: 2027-01-02
Participants
Target number of participants: 120
Treatments
Experimental: Smart flex stent group
Smart flex stent will be used for patients with femoropopliteal lesions receiving endovascular treatment.
Sponsors
Collaborators: Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology, Xuanwu Hospital, Beijing, Fudan University, First Affiliated Hospital of Zhejiang University, Dongfang Hospital Beijing University of Chinese Medicine, First People's Hospital of Hangzhou, Xiamen Cardiovascular Hospital, Xiamen University, Second Affiliated Hospital of Soochow University, Qingdao Haici Hospital
Leads: RenJi Hospital

This content was sourced from clinicaltrials.gov