Femoropopliteal Disease
Conditions
Keywords
Embolic Protection System, Distal embolism, Debulking
Brief summary
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).
Interventions
DEVICEEmbolic Protection System
Using Embolic Protection System for preventing distal embolism during femoropopliteal endovascular debulking procedures
Sponsors
Xuanwu Hospital, Beijing
First Affiliated Hospital of Zhejiang University
Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
Huashan Hospital
Shanghai Zhongshan Hospital
Qingdao Haici Hospital
Ruijin Hospital
Xiamen Cardiovascular Hospital, Xiamen University
Chengdu University of Traditional Chinese Medicine
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Affiliated Hospital of Nantong University
RenJi Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \> 18 years 2. Rutherford classification 2-5 3. Patients with chronic femoropopliteal obstruction or thromboembolism who require debulking prior to other endovascular treatments. 4. 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 5. The guidewire needs to pass through the lesion 6. Life expectancy \>24 months 7. Moderate to severe calcified lesions confirmed by imaging 8. For patients who receive intervention in both lower extremities, they may be enrolled in order of time of endovascular therapy 9. For combined aortoiliac artery lesions, recanalization of blood flow through endoluminal reconstruction of the vessel without more than 50% residual stenosis.
Exclusion criteria
1. Patients with stroke, cerebral hemorrhage, gastrointestinal hemorrhage, or cardiac infarction within 3 months prior to enrollment 2. Patients with known allergy to heparin, aspirin, other antiplatelet drugs, contrast agents, etc. 3. 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; 4. Pregnant and lactating women 5. Patients who are unable or unwilling to participate in this trial 6. patients with Berger's disease 7. Patients who have undergone arterial bypass on the treated side
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 30-day freedom from Major adverse events (MAEs) | 30 days after intervention | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device Success Rate | Immediately after intervention | 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 | Immediately after intervention | Defined as: successful revascularization without termination of operation due to device |
Countries
China
Contacts
Primary ContactQihong Ni
Outcome results
None listed