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A Study of Endovascular Treatment of Femoropopliteal Arterial Occlusive Lesion With Drug-Coated Balloon

NCT04826705 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 2000

Last updated 2024-03-05

No results posted yet for this study

Summary

There have been a number of randomized controlled studies (RCT) showing the efficacy of the endovascular treatment with drug-coated balloons (DCB) in the femoropopliteal artery lesions. However, these studies have been carefully designed, and most of them have excluded long-length lesions and severely calcified lesions. In addition to being used alone in the real word, drug-coated balloons (DCB) are also used in combination with stents or debulking devices, but in these randomized controlled studies (RCT) they are only compared with standard percutaneous transluminal angioplasty (PTA). Therefore, the investigators initiated this study, which is a prospective, multicenter, observational real-world study of short and long-term outcome in endovascular treatment of femoropopliteal arterial occlusive lesions with DCB.

Conditions

  • Drug-coated Balloon
  • Femoropopliteal Artery Occlusion
  • Angioplasty

Interventions

DEVICE

Drug-coated Balloon

To observe the effectiveness and safety of the drug-coated balloon in the treatment of lower extremity arteriosclerosis obliterans of the femoral popliteal artery segment.

Sponsors & Collaborators

  • RenJi Hospital

    collaborator OTHER

  • Zhejiang University

    collaborator OTHER

  • Xuanwu Hospital, Beijing

    collaborator OTHER

  • First People's Hospital of Hangzhou

    collaborator OTHER

  • Second Affiliated Hospital of Suzhou University

    collaborator OTHER

  • Qingdao University

    collaborator OTHER

  • Chengdu University of Traditional Chinese Medicine

    collaborator OTHER

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

    lead OTHER

Principal Investigators

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

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2025-02-01
Completion
2027-02-01

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 NCT04826705 on ClinicalTrials.gov