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
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