The purpose of this study is to evaluate the efficacy and safety of RESTORE Paclitaxel eluting balloon in the treatment of Chinese patients with coronary heart disease and small vessel lesions in comparison with RESOLUTE Zotarolimus eluting stent.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
240
Beijing Anzhen Hospital,Capital Medical University
Beijing, Beijing Municipality, China
Fuwai Hospital, CAMS&PUMC
Beijing, Beijing Municipality, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
In-segment diameter stenosis(%).
Time frame: 9 months after the operation.
The success rate of intervention treatment (%),including device success, lesion success and clinical success.
Time frame: 1-2 days.
In-device diameter stenosis (%) of the target lesion.
Time frame: 9 months after the operation.
cardiac death.
Time frame: in month-1, 6, 9, 12 and year-2, 3, 4, 5.
myocardial infarction related to the target vessel.
Time frame: in month-1, 6, 9, 12 and year-2, 3, 4, 5.
target lesion revascularization driven by ischemia.
Time frame: in month-1, 6, 9, 12 and year-2, 3, 4, 5.
all-cause death
Time frame: in month-1, 6, 9, 12 and year-2, 3, 4, 5.
myocardial infarction
Time frame: in month-1, 6, 9, 12 and year-2, 3, 4, 5.
any target lesion revascularization
Time frame: in month-1, 6, 9, 12 and year-2, 3, 4, 5.
acute thrombosis
Time frame: in month-1, 6, 9, 12 and year-2, 3, 4, 5
sub-acute thrombosis
Time frame: in month-1, 6, 9, 12 and year-2, 3, 4, 5
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Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Daqing Oilfield General Hospital
Daqing, Heilongjiang, China
Wuhan Asia Heart Hospital
Wuhan, Hubei, China
Xiangya Hospital Central South University
Changsha, Hunan, China
Nanjing Drum Tower Hospital, The Affiliated Hospital of Najing University Medical School
Nanjing, Jiangsu, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
...and 2 more locations
end-stage thrombosis
Time frame: in month-1, 6, 9, 12 and year-2, 3, 4, 5
delayed thrombosis
Time frame: in month-1, 6, 9, 12 and year-2, 3, 4, 5