The Safety and Efficiency of Endovascular Treatment of Acute or Subacute Thromboembolic Occlusions of Lower Extremity.

Summary

Based on the development of new tools, including drug coated balloon, paclitaxel eluting stent, interwoven stents, debulking tools, More and more acute or subacute thromboembolic occlusions of lower extremity included stage IIb were treated with endovascular procedures. Most guidelines suggests only stage I and stage IIa lesions are suitable for endovascular treatments. Therefore, a well-designed real-world study that track the safety and clinical relevant outcomes, are required to determine the optimal therapies for patients with acute or subacute thromboembolic occlusions of lower extremity.

Conditions

• Thromboembolic Disease
• Lower Extremity Problem
• Endovascular Treatment
• Safety Issues
• Efficacy, Self

Interventions

PROCEDURE

endovascular treatment

All the patients are treated by endovascular therapy, through contralateral femoral artery approach, ipsilateral antegrade femoral artery approach or brachial artery approach. If the lesion is difficult to pass in antegrade approach, retrograde puncture at the distal artery of the lesion can be performed. Surgeons can choose treatment methods such as pharmacomechanical thrombectomy (PMT) and mechanical thrombectomy device (MTD) and/or pharmacomechanical thrombectomy (PMT）and/or percutaneous aspiration thrombectom (PAT) and/or CDT(catheter-directed thrombolysis) and/or percutaneous aspiration thrombectom (PAT) thrombolysis (CDT) for thrombus removal according to the characteristics of the lesions and hospital conditions.

Sponsors & Collaborators

• RenJi Hospital

  collaborator OTHER

• First Affiliated Hospital of Zhejiang University

  collaborator OTHER

• Xuanwu Hospital, Beijing

  collaborator OTHER

• Qingdao Haici Hospital

  collaborator OTHER

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

  collaborator OTHER

• Second Affiliated Hospital of Suzhou University

  collaborator OTHER

• Chengdu University of Traditional Chinese Medicine

  collaborator OTHER

• Shanghai Zhongshan Hospital

  collaborator OTHER

• First People's Hospital of Hangzhou

  lead OTHER

Principal Investigators

• Meng Ye · RenJi Hospital

• Ziheng Wu · First Affiliated Hospital of Zhejiang University

• Lianrui Guo · Xuanwu Hospital, Beijing

• Qiang Li · Qingdao Haici Hospital

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

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

• Chunshui He · Chengdu University of Traditional Chinese Medicine

• Zhenyu Shi · Shanghai Zhongshan Hospital

• Xupin Xie · First People's Hospital of Hangzhou

• Jianyun Long · First People's Hospital of Hangzhou

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-04-01

Primary Completion

2025-12-31

Completion

2025-12-31

Countries

• China

Study Locations