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Angioplasty With Shockwave IVL Catheter System in Femoropopliteal Lesions

NCT06713850 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 130

Last updated 2024-12-03

No results posted yet for this study

Summary

There is a lack of prospective observational studies of shockwave balloons in the treatment of moderate-to-severe calcification of the femoral popliteal artery at the international level. Therefore, in this study, we wish to set up a real-world study of shockwave balloon in the treatment of moderate-to-severe calcification to investigate the real-world efficacy of shockwave balloon in the treatment of moderate-to-severe calcified lesions.

Conditions

  • Peripheral Artery Disease (PAD)
  • Chronic Limb Threatening Ischemia

Interventions

DEVICE

Shockwave balloons

To evaluate the effectiveness and safety of the Shockwave intraperipheral shockwave catheter system in peripheral arterial angioplasty.

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    collaborator OTHER

  • Huashan Hospital

    collaborator OTHER

  • Xuanwu Hospital, Beijing

    collaborator OTHER

  • The General Hospital of Southern Theater Command

    collaborator OTHER

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

    collaborator OTHER

  • RenJi Hospital

    collaborator OTHER

  • Chengdu University of Traditional Chinese Medicine

    collaborator OTHER

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

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2027-11-30
Completion
2028-11-30

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 NCT06713850 on ClinicalTrials.gov