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Impact of Tibial Run Off on Clinical Outcome of Endovascular Therapy in Femoropopliteal Lesions (TALENT Study)

NCT04675632 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1200

Last updated 2025-08-03

No results posted yet for this study

Summary

This study is a prospective, multicenter, real world, observational study intended to understand the impact of tibial run off on clinical outcome of endovascular therapy in Femoropopliteal lesions. It is estimated that 1200 patients with chronic femoral popliteal artery occlusion were enrolled in the group at 8 centers nationwide from January 2021 to December 2022. Two groups would be divided according to whether or not the tibial run off intervened for reconstruction. The intervention group and the non-intervention group. The intervention group would be evaluated Run-off score again after the tibial run off reconstructed. The the Society for Vascular Surgery(SVS) run-off score would be used for the score of the tibial run off. The total score of the tibial run off would be 19 points, 1 point indicating healthy run off. According to the quality of the run off, the preoperative patients would be divided into 1-5, 6-10, 11-15, and \>15 points. The follow-up would be conducted at 1, 6, 12, 18 and 24 months after the operation. As it is a real world study, there is no determined end point.The main indicators would be observed including the reintervention rate driven by lesions' clinical symptoms, the rate of primary patency of the femoral popliteal artery, the improvement of quality of life score and rutherford grading.

Conditions

  • Femoropopliteal Artery Occlusion

Interventions

PROCEDURE

Endovascular Therapy

the most commonly used surgical options include: ordinary balloon dilatation， drug-coated balloon (DCB) dilatation and bare stent implantation.

Sponsors & Collaborators

  • Chengdu University of Traditional Chinese Medicine

    lead OTHER

Principal Investigators

  • Meng Ye, doctor · RenJi Hospital

  • Ziheng Wu, doctor · Zhejiang University

  • Lianrui Guo, doctor · Xuanwu Hospital, Beijing

  • Xin Fang, doctor · Hangzhou First People's hospital of Medical College of Zhejiang University

  • Hongfei Sang, doctor · Second Affiliated Hospital of Suzhou University

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

  • Qiang Li, doctor · Qingdao Haici Hospital

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-04
Primary Completion
2025-06-30
Completion
2025-06-30

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 NCT04675632 on ClinicalTrials.gov