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.
Study Type
OBSERVATIONAL
Enrollment
300
Hiser Medical Group
Qingdao, Shandong, China
RECRUITINGMajor adverse events
Major adverse events at 30days
Time frame: post-interventional 30days
freedom from target lesion revascularization
freedom from target lesion revascularization at 2years
Time frame: post-interventional 2 years
Technical success rate
Time frame: post-intervention
Time of surgery
Time frame: post-intervention
Time of hospital stay
Time frame: post-hospitalization
primary patency of CFA
primary patency of CFA at 1,3,6, 9,12 and 24 month
Time frame: 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
Time frame: 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
Time frame: post-interventional 1,3,6, 9,12 month
Perioperative complications
Perioperative complications at 30days
Time frame: post-interventional 30days
Direct and indirect medical expenditures associated with the disease
Direct and indirect medical expenditures associated with the disease at 24months
Time frame: post-hospitalization 24 months
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