endovascular treatment
ProcedureThe bare metal stent covers the deep femoral artery lower than 50%
NCT Number: NCT04713865
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(10) The lower extremity artery needs to have a healthy runoff of no less than 10 cm above the ankle, and at least one healthy dorsalis pedis artery, medial or lateral plantar artery connected with the digital artery below the ankle (11) Informed consent signed by patients
Exclusion criteria
(8) Use of thrombectomy, atherectomy or laser devices during procedure (9) Previous open surgery in the same limb . (10) Patients with deep femoral artery totally occlusion
The bare metal stent covers the deep femoral artery lower than 50%
Time frame: post-interventional 48 months
Major adverse events and freedom from target lesion revascularization at 48 months
Time frame: post-interventional 1,6, 12,24,36 and 48 month
primary patency of PFA and bare metal stent at 1,6, 12,24,36 and 48 month
Time frame: post-interventional 1,6, 12,24,36 month
Major adverse events at 1,6, 12,24,36 month
Time frame: post-interventional 1,6, 12,24,36 month
freedom from target lesion revascularization at 1,6, 12,24,36 month
Qingdao Hiser Medical Group
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.