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

NCT04675632 | Completed

• 1 other identifier: ChengduUTCMvs2
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

femoropopliteal artery occlusion; run off score; endovascular therapy

Outcome Measures

Primary Outcomes (2)

• the clinically driven target lesion revascularization(CD-TLR) rate at post-interventional

  Any reintervention within the target lesion due to symptoms or drop of ABI≥20% or \>0.15 when compared to post-index procedure baseline ABI.

  24 months

• Changes of the patency rate of target(Femoropopliteal) lesions at post-interventional

  the patency rate of target(Femoropopliteal) lesions would be determined by vascular ultrasound,Restenosis would be diagnosed if the peak systolic velocity ratio(PSVR)≥2. 5.

  baseline and 24 months

Secondary Outcomes (4)

• vascular quality of life questionnaire(VascuQol)

  1 month,6 months,12 months,18 months and 24 months

• Wound,Ischemia,and foot infection(WIFI) classification system

  1 month,6 months,12 months,18 months and 24 months

• Changes of rutherford grade

  1 month,6 months,12 months,18 months and 24 months

• Incidence of perioperative adverse events

  1 month,6 months,12 months,18 months and 24 months

Study Arms (2)

The intervention group

the tibial run off would be treated through endovascular therapy

Procedure: Endovascular Therapy

the non-intervention group

the tibial run off would not be treated through endovascular therapy

Interventions

Endovascular Therapy PROCEDURE

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

The intervention group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Arteriosclerosis obliterans of lower extremities

You may qualify if:

• \) Rutherford stages 2-5. 2) The femoral and popliteal artery as the target of the study has at least ≥70% stenosis or occlusion.
• \) Whether it is a primary femoral and popliteal artery disease or in-stent restenosis, patients who received endovascular recanalization successfully (Residual stenosis \<30% and no flow-limiting arterial dissection) can be enrolled in the group.
• \) For the patients with both lower limbs to be treated, both limbs can be selected into the group.
• \) Patients who failed the first treatment because the guide wire could not pass through the lesion can still be included in the group after successful endovascular interventional treatment.
• \) Patients who understand the purpose of this research, volunteer to participate in the experiment, sign an informed consent form and are willing to be followed up can be included in the experiment.
• \) For ipsilateral aortoiliac artery disease, patients with residual stenosis \<30% can also be included in the group after intravascular reconstruction.

You may not qualify if:

• \) Patients with acute arterial thrombosis. 2) Patients with serum creatinine level\> 176μmol/L. 3) Patients with Rutherford stage 5 have foot infection grades of 2 and 3 in the preoperative WIFI (WIfI) classification.
• \) Limbs that have been treated with the femoral and popliteal artery bypass surgery.
• \) Patients who are known to be allergic or sensitive to contrast agents, heparin, aspirin (ASA), other anticoagulant or antiplatelet therapies, and/or paclitaxel.
• \) Patients with bleeding constitution. 7) Pregnant and lactating women. 8) Patients with a history of myocardial infarction or unstable angina within 3 months.

Sponsors & Collaborators

• Chengdu University of Traditional Chinese Medicine: lead

Study Sites (1)

Chunshuihe

Chengdu, Sichuan, 610000, China

Location

Related Publications (1)

• Liu Y, Wang Q, Wu Z, Fen Z, Guo L, Li Q, Fang X, Sang H, Dai Y, He C, Ye M. A prospective, multicenter, real-world observational study evaluating the impact of tibial runoff on clinical outcomes after endovascular therapy for femoropopliteal lesions: Research protocol. Front Cardiovasc Med. 2022 Nov 16;9:1035659. doi: 10.3389/fcvm.2022.1035659. eCollection 2022.

  PMID: 36465469 DERIVED

Study Officials

• Meng Ye, doctor

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

• Ziheng Wu, doctor

  Zhejiang University

  PRINCIPAL INVESTIGATOR

• Lianrui Guo, doctor

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

• Xin Fang, doctor

  Hangzhou First People's hospital of Medical College of Zhejiang University

  PRINCIPAL INVESTIGATOR

• Hongfei Sang, doctor

  Second Affiliated Hospital of Suzhou University

  PRINCIPAL INVESTIGATOR

• Zibo Feng, doctor

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

  PRINCIPAL INVESTIGATOR

• Qiang Li, doctor

  Qingdao Haici Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: the director of the vascular surgery of Hospital of Chengdu University of Traditional Chinese Medicine

Study Record Dates

• First Submitted: December 6, 2020
• First Posted: December 19, 2020
• Study Start: January 4, 2021
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: August 3, 2025

Record last verified: 2025-07

Locations

CN (1)