The purpose of this study is to determine whether DEB is more effective than common PTA balloon in long-term vessel patency and inhibiting restenosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
200
Xiyuan Hospital CACMS
Beijing, Beijing Municipality, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Late Lumen Loss
measure difference of the MLD(minimal lumen diameter) at 0 time and 6 months
Time frame: 6 months
Minimal lumen diameter (MLD)
measure minimal lumen diameter (MLD) of target lesion
Time frame: 6 months
Restenosis rate of target vessel
stenosis over 50% is defined as restenosis
Time frame: 6 months, 12 months, 18 months, 24months
target lesion revascularization
target lesion revascularization is defined as any reintervention of artery bypass graft surgery involving the target lesion
Time frame: 6 months, 12 months, 18 months, 24 months
change in Rutherford stage
based the following definition of Rutherford stage, evaluate the stage of patient. Then compare the stage of patient just after procedure and 6 months after treatment Stage clinical symptom 0 asymptomatic 1. mild claudication 2. moderate claudication 3. severe claudication 4. ischemic rest pain 5. minor tissue loss 6. ulceration or gangrene
Time frame: 6 months, 12 months, 18 months, 24 months
change in ankle brachial index(ABI)
change in ankle brachial index(ABI) compared to pretreatment
Time frame: 6 months
major amputation
major amputation at the index limb(major amputation is defined as an amputation above the foot)
Time frame: 6 months, 12 months, 18 months, 24 months
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The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
The second Hospital Of Hebei University
Shijiazhuang, Hebei, China
The First Affiliated Hospital, Dalian Medical University
Dalian, Liaoning, China
The People's Hospital of Liaoning Province
Shenyang, Liaoning, China
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Renji Hospital ShangHai Jiaotong University School Of Medicine
Shanghai, Shanghai Municipality, China
Death
death of any cause
Time frame: 12 months, 18 months, 24 months