Evaluation of the Clinical Outcomes of the Embolic Protection System in Preventing Distal Embolism During Femoropopliteal Debulking Procedures
NCT ID: NCT07282301
Last Updated: 2025-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
150 participants
OBSERVATIONAL
2025-10-20
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Embolic Protection System during femoropopliteal endovascular debulking
Using Embolic Protection System for preventing distal embolism during femoropopliteal endovascular debulking
Embolic Protection System
Using Embolic Protection System for preventing distal embolism during femoropopliteal endovascular debulking procedures
Interventions
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Embolic Protection System
Using Embolic Protection System for preventing distal embolism during femoropopliteal endovascular debulking procedures
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Xuanwu Hospital, Beijing
OTHER
First Affiliated Hospital of Zhejiang University
OTHER
Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
OTHER
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
RenJi Hospital
OTHER
Responsible Party
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Locations
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Renji Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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the EPISODE study
Identifier Type: -
Identifier Source: org_study_id
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