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Evaluation of the Clinical Outcomes of the Embolic Protection System in Preventing Distal Embolism During Femoropopliteal Debulking Procedures

NCT07282301 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2025-12-15

No results posted yet for this study

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).

Conditions

  • Femoropopliteal Disease

Interventions

DEVICE

Embolic Protection System

Using Embolic Protection System for preventing distal embolism during femoropopliteal endovascular debulking procedures

Sponsors & Collaborators

  • Xuanwu Hospital, Beijing

    collaborator OTHER

  • First Affiliated Hospital of Zhejiang University

    collaborator OTHER

  • Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology

    collaborator OTHER

  • Huashan Hospital

    collaborator OTHER

  • Shanghai Zhongshan Hospital

    collaborator OTHER

  • Qingdao Haici Hospital

    collaborator OTHER

  • Ruijin Hospital

    collaborator OTHER

  • Xiamen Cardiovascular Hospital, Xiamen University

    collaborator OTHER

  • Chengdu University of Traditional Chinese Medicine

    collaborator OTHER

  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    collaborator OTHER

  • Affiliated Hospital of Nantong University

    collaborator OTHER

  • RenJi Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-20
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07282301 on ClinicalTrials.gov