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A Real-world Study to Evaluate the Primary Patency and Freedom From TLR of Endovascular Treatment in TOSAKA III In-stent Restenosis of Lower Extremity Femoropopliteal Artery.

NCT04801004 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 322

Last updated 2026-03-25

No results posted yet for this study

Summary

This study is a prospective, multi-center, real world, observational study, which aims at evaluating the safety, efficacy and economic cost of endovascular treatments for endovascular therapies in tosaka III (totally occluded) in-stent restenosis.It is estimated that 300 subjects diagnosed with tosaka III in-stent restenosis and receive endovascular treatments will be enrolled in nine centers from April 2021 to December 2022 nation-widely. All the subjects will be under follow-up for 24 months. There is no restriction on the endovascular techniques. The primary outcomes include clinical-driven freedom from TLR at 24 months.

Conditions

  • Peripheral Arterial Disease

Sponsors & Collaborators

  • RenJi Hospital

    collaborator OTHER

  • First Affiliated Hospital of Zhejiang University

    collaborator OTHER

  • Chengdu University of Traditional Chinese Medicine

    collaborator OTHER

  • Xuanwu Hospital, Beijing

    collaborator OTHER

  • First People's Hospital of Hangzhou

    collaborator OTHER

  • Qingdao Hiser Medical Group

    collaborator OTHER

  • Second Affiliated Hospital of Soochow University

    collaborator OTHER

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

    collaborator UNKNOWN

  • Shanghai Zhongshan Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2025-06-01
Completion
2026-03-01

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 NCT04801004 on ClinicalTrials.gov