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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
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
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