Patients with femoropopliteal arterial lesions requiring debulking procedures. The objective of this study is Evaluation of the clinical outcomes of the Embolic Protection System for preventing distal embolism during femoropopliteal endovascular debulking procedures (The EPISODE study).
Age > 18 years
Rutherford classification 2-5
Patients with chronic femoropopliteal obstruction or thromboembolism who require debulking prior to other endovascular treatments.
Patients who understand the purpose of this study, participate in the study voluntarily, sign the informed consent and are willing to receive follow-up visits
Patients with stroke, cerebral hemorrhage, gastrointestinal hemorrhage, or cardiac infarction within 3 months prior to enrollment
Patients with known allergy to heparin, aspirin, other antiplatelet drugs, contrast agents, etc.
Patients who have been treated with drugs that interfere with this clinical trial or intraoperatively with other special vascular bed preparation devices, such as plaque volume reduction devices, special balloons, etc., within the last 3 months;
Pregnant and lactating women
Patients using Embolic Protection System for preventing distal embolism during femoropopliteal endovascular debulking procedures
Cohort
Prospective
Embolic Protection System
DeviceUsing Embolic Protection System for preventing distal embolism during femoropopliteal endovascular debulking procedures
30-day freedom from Major adverse events (MAEs)
Incidence of no major adverse events within 30 days. Major adverse event is defined as death; acute cardiac infarction; unplanned amputation; acute thrombosis of the target vessel; serious complications related to the filter, such as vessel perforation, detachment of the filter, and severe entrapment (type D,E,F); distal embolism with clear clinical signs (specifically, the presence of imaging evidence of clear distal embolism at the distal end of the filter, with severe manifestations of ischemia that require further endoluminal or surgical intervention for relief, or cause tissue damage/longer hospitalization).
Device Success Rate
Defined as: the filter passes through the lesion smoothly and is fully released distal to the lesion, and could be retrieved smoothly at the end of the treatment without serious vascular entrapment, distal embolization, or vascular perforation during release and retrieval
Technical success rate
Defined as: successful revascularization without termination of operation due to device
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RenJi Hospital
Lead sponsor
Xuanwu Hospital, Beijing
Collaborator
First Affiliated Hospital of Zhejiang University
Collaborator
Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
Collaborator
Huashan Hospital
Collaborator
Shanghai Zhongshan Hospital
Collaborator
Qingdao Haici Hospital
Collaborator
Ruijin Hospital
Collaborator
Xiamen Cardiovascular Hospital, Xiamen University
Collaborator
Chengdu University of Traditional Chinese Medicine
Collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Collaborator
Affiliated Hospital of Nantong University
Collaborator
