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NCT04826705

A Study of Endovascular Treatment of Femoropopliteal Arterial Occlusive Lesion With Drug-Coated Balloon

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

View on ClinicalTrials.gov

Summary

There have been a number of randomized controlled studies (RCT) showing the efficacy of the endovascular treatment with drug-coated balloons (DCB) in the femoropopliteal artery lesions. However, these studies have been carefully designed, and most of them have excluded long-length lesions and severely calcified lesions. In addition to being used alone in the real word, drug-coated balloons (DCB) are also used in combination with stents or debulking devices, but in these randomized controlled studies (RCT) they are only compared with standard percutaneous transluminal angioplasty (PTA). Therefore, the investigators initiated this study, which is a prospective, multicenter, observational real-world study of short and long-term outcome in endovascular treatment of femoropopliteal arterial occlusive lesions with DCB.

Official title: A Prospective, Multicenter, Observational Study of Short and Long-term Outcome in Endovascular Treatment of Femoropopliteal Arterial Occlusive Lesion With Drug-Coated Balloon (PROMISING Study)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

2000

Start Date

2021-02-01

Completion Date

2027-02-01

Last Updated

2024-03-05

Healthy Volunteers

No

Interventions

DEVICE

Drug-coated Balloon

To observe the effectiveness and safety of the drug-coated balloon in the treatment of lower extremity arteriosclerosis obliterans of the femoral popliteal artery segment.

Locations (9)

Zibo Feng

Wuhan, Hubei, China

Xuanwu Hospital Capital Medical University

Beijing, China

Hospital of Chengdu University of Traditional Chinese Medicine

Chengdu, China

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

Hangzhou, China

the First Affiliated hospital of Medicine College of Zhejiang University

Hangzhou, China

Qingdao Haici hospital affiliated to Qingdao University

Qingdao, China

Renji Hospital of Shanghai Jiaotong University

Shanghai, China

Zhongshan Hospital of Fudan University

Shanghai, China

the second Affiliated Hospital of Medical College of Suzhou University

Suzhou, China