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| Name | Class |
|---|---|
| Xuanwu Hospital, Beijing | OTHER |
| First Affiliated Hospital of Zhejiang University | OTHER |
| Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Embolic Protection System during femoropopliteal endovascular debulking | Using Embolic Protection System for preventing distal embolism during femoropopliteal endovascular debulking |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Embolic Protection System | Device | Using Embolic Protection System for preventing distal embolism during femoropopliteal endovascular debulking procedures |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 30 days after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Immediately after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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Patients using Embolic Protection System for preventing distal embolism during femoropopliteal endovascular debulking procedures
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qihong Ni | Contact | 15801900772 | niqihong1989@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital | Recruiting | Shanghai | Shanghai Municipality | 200217 | China |
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| Huashan Hospital | OTHER |
| Shanghai Zhongshan Hospital | OTHER |
| Qingdao Haici Hospital | OTHER |
| Ruijin Hospital | OTHER |
| Xiamen Cardiovascular Hospital, Xiamen University | OTHER |
| Chengdu University of Traditional Chinese Medicine | OTHER |
| Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
| Affiliated Hospital of Nantong University | OTHER |
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| Technical success rate |
Defined as: successful revascularization without termination of operation due to device |
| Immediately after intervention |