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This study is a prospective, multicenter real-world observational study to understand the safety and efficacy of endoluminal therapy and traditional endometristomy in the real world for patients with severe stenosis and occlusion of the common femoral artery. The study will enroll 300 patients with severe stenosis and occlusion of chronic common femoral artery in nine centers across the country. According to the different intervention methods of the common femoral artery, the enrolled cases were divided into two groups: A: endometrial detachment for common femoral artery lesions and B: interventional endovascular treatment for common femoral artery lesions. As it is a real-world study, there is no separate primary endpoint indicator, which mainly observes F-TLR (immunity from vascular re-intervention), technical success rate, duration of surgery, length of hospital stay, common femoral artery patency rate, deep femoral artery patency rate, direct and indirect medical expenditure associated with the disease in 24 months, MAE (major adverse events), and perioperative complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CFA treated by endarterectomy | Common femoral artery lesions undergo endometrial decortication | ||
| CFA treated by transluminal extraction-atherectomy | Common femoral artery lesions are treated intravenously |
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| Measure | Description | Time Frame |
|---|---|---|
| Major adverse events | Major adverse events at 30days | post-interventional 30days |
| freedom from target lesion revascularization | freedom from target lesion revascularization at 2years | post-interventional 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success rate | post-intervention | |
| Time of surgery | post-intervention | |
| Time of hospital stay |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with severe chronic primary stenosis or occlusion of the common femoral artery (including the femoral artery bifurcation) requiring endovascular therapy or plaque stripping were enrolled
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| qiang Li | Contact | 17669757601 | liyu6588@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hiser Medical Group | Recruiting | Qingdao | Shandong | China |
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| post-hospitalization |
| primary patency of CFA | primary patency of CFA at 1,3,6, 9,12 and 24 month | post-interventional 1,3,6, 9,12 and 24 month |
| primary patency of PFA | primary patency of CFA at 1,3,6, 9,12 and 24 month | post-interventional 1,3,6, 9,12 and 24 month |
| freedom from target lesion revascularization | freedom from target lesion revascularization at 1,3,6, 9,12 month | post-interventional 1,3,6, 9,12 month |
| Perioperative complications | Perioperative complications at 30days | post-interventional 30days |
| Direct and indirect medical expenditures associated with the disease | Direct and indirect medical expenditures associated with the disease at 24months | post-hospitalization 24 months |