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The Acute and Long-term Clinical Outcome of Self- Expandable Stent in Complex Proximal Superficial Femoral Artery Lesions Involving the Femoral Bifurcation
Sponsor: Qingdao Hiser Medical Group
Summary
The stent-FP study investigates the impact of coverage of profound femoral artery (PFA) by bare metal stent deployed in proximal superficial femoral artery (SFA) lesions. 300 patients with femoral bifurcation lesions will be included and divided into 3 groups according to the location of proximal stent edge. The primary endpoint of the study is major adverse events and freedom from target lesion revascularization at 48 months. Secondary endpoints include primary patency of PFA and bare metal stent at 1,6, 12,24,36and 48 month, MAE and F -TLR at 1,6, 12,24,36 month.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
300
Start Date
2021-08-18
Completion Date
2026-08-17
Last Updated
2021-08-19
Healthy Volunteers
Not specified
Conditions
Interventions
endovascular treatment
The bare metal stent covers the deep femoral artery lower than 50%
endovascular treatment
The bare metal stent covers the deep femoral artery in 50-90%
endovascular treatment
The bare metal stent totally covers the deep femoral artery