Post-marketing Study in Femoral Popliteal Artery of Drug Coated Balloon Used for Treatment of Lower Limb Ischemia
NCT ID: NCT05498740
Last Updated: 2022-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2022-05-04
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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drug eluting balloon catheter
use drug eluting balloon catheter to treat the stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery
Drug eluting Balloon
Drug eluting Balloon is a kind of the product that has been used for many years. By filling the micropores on the surface of the balloon with anti-proliferative drugs like immunosuppressive agents, the balloon is expanded and contacted with the lesion to rapidly release the drug to the local arterial wall.
Interventions
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Drug eluting Balloon
Drug eluting Balloon is a kind of the product that has been used for many years. By filling the micropores on the surface of the balloon with anti-proliferative drugs like immunosuppressive agents, the balloon is expanded and contacted with the lesion to rapidly release the drug to the local arterial wall.
Eligibility Criteria
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Inclusion Criteria
2. Rutherford clinical category classification：2-5
3. Significant stenosis (≥50%) or occlusions of lesion(s) located in the superficial femoral artery an /or the popliteal artery
4. At least one patent native outflow artery to the ankle free from significant lesion as confirmed by angiography
5. Subject has provided written informed consent prior to participation , understands the purpose of this trail and agrees to comply with all protocol-specified examinations and follow-up appointments.
Exclusion Criteria
2. The guide wire cannot pass smoothly through the target lesion.
3. Known allergy to contrast agents, heparin or paclitaxel.
4. Patient already enrolled in other investigational (interventional) studies that would interfere with study endpoints or may enroll in other studies after enrollment in this clinical trial.
5. Pregnancy or female patient with child bearing potential not taking adequate contraceptives or currently lactating.
6. Other comorbidities, which in the opinion of the investigator limit longevity or likelihood of compliance with protocol follow up.
18 Years
85 Years
ALL
Yes
Sponsors
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Zhejiang Zylox Medical Device Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Weiguo Fu
Role: PRINCIPAL_INVESTIGATOR
Shanghai Zhongshan Hospital
Locations
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Xuanwu hospital
Beijing, , China
Affiliated Hospital of Chengde Medical College
Chengde, , China
The Third People's Hospital of Chengdu
Chengdu, , China
The First Affiliated Hospital of Dalian Medical University
Dalian, , China
The Second Affiliated Hospital of Dalian Medical University
Dalian, , China
Guangzhou Huaqiao hospital
Guangzhou, , China
Hospital of Traditional Chinese Medicine affiliated to Guangzhou Medical University
Guangzhou, , China
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, , China
Hangzhou First People's Hospital
Hangzhou, , China
The First Affiliated Hospital of Harbin Medical University
Ha’erbin, , China
First Hospital of Lanzhou University
Lanzhou, , China
Ningbo huamei hospital
Ningbo, , China
Qingdao Municipal Hospital
Qingdao, , China
Ruian People's Hospital
Rui’an, , China
Shanghai Ninth People'S Hospital
Shanghai, , China
Zhongshan Hospital
Shanghai, , China
Northern Theatre General Hospital
Shenyang, , China
Tianjin Medical University General Hospital
Tianjin, , China
Tianjin People's Hospital
Tianjin, , China
Weifang People's Hospital
Weifang, , China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, , China
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, , China
The First Affiliated Hospital of Xi 'an Jiaotong University School of Medicine
Xi'an, , China
People's Hospital of Xinjiang Uygur Autonomous Region
Xinjiang, , China
Countries
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Central Contacts
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Facility Contacts
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Yongquan Gu
Role: primary
Hong Zhang
Role: primary
Chi Cui
Role: primary
Ming Qi
Role: primary
Lei Song
Role: primary
Yan Zhang
Role: primary
Meng Du
Role: primary
Chenyu Yang
Role: primary
Xin Fang
Role: primary
Bing Liu
Role: primary
Xiaojun Shu
Role: primary
Dehai Lang
Role: primary
Dalin Li
Role: primary
Changsheng Shi
Role: primary
Minyi Yin
Role: primary
Weiguo Fu
Role: primary
Hong Jiang
Role: primary
Xiangchen Dai
Role: primary
Li Su
Role: primary
Jiefeng Zhang
Role: primary
Jingyong Huang
Role: primary
Xiangtao Zheng
Role: primary
Hongyan Tian
Role: primary
Sheng Guan
Role: primary
Other Identifiers
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04202106
Identifier Type: -
Identifier Source: org_study_id
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