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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PFA slightly jailed by proximal SFA stent(100 pts) |
| ||
| PFA moderately jailed by proximal SFA stent(100 pts) |
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| PFA totally jailed by proximal SFA stent (100pts) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endovascular treatment | Procedure | The bare metal stent covers the deep femoral artery lower than 50% |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse events and freedom from target lesion revascularization | Major adverse events and freedom from target lesion revascularization at 48 months | post-interventional 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| primary patency of PFA and bare metal stent | primary patency of PFA and bare metal stent at 1,6, 12,24,36 and 48 month | post-interventional 1,6, 12,24,36 and 48 month |
| MAE | Major adverse events at 1,6, 12,24,36 month |
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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
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Patiens with De novo lesions located in the femoral artery bifurcation (5mm between distal CFA and proximal SFA), need for primary bare metal stent implantation
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| endovascular treatment | Procedure | The bare metal stent covers the deep femoral artery in 50-90% |
|
| endovascular treatment | Procedure | The bare metal stent totally covers the deep femoral artery |
|
| post-interventional 1,6, 12,24,36 month |
| F -TLR | freedom from target lesion revascularization at 1,6, 12,24,36 month | post-interventional 1,6, 12,24,36 month |