The purpose of this study was to evaluate the safety and efficacy of intravascular high-pressure cut balloon catheter compared to cut balloon catheter during PCI, and to support product registration and clinical application.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
168
The subjects underwent immediate coronary angiography after Percutaneous transluminal coronary angioplasty to evaluate the success rate of instruments, and immediate coronary angiography after PCI to evaluate the success rate of clinical treatment
the First Affiliated Hospital of USTC
Hefei, Anhui, China
Zhongshan Hospital Affiliated to Xiamen University
Xiamen, Fujian, China
Daqing Oilfield General Hospital
Daqing, Heilongjiang, China
Device Procedural Success Rate
In the case of balloon dilatation and stenosis, balloon delivery, balloon filling and dilatation, balloon withdrawal pressure retraction and successful balloon retraction can be successfully completed. After balloon dilatation, residual stenosis of the target lesion is less than 50%
Time frame: immediately after PTCA
Clinical Success Rate
The residual lumen stenosis of the target lesion after surgery was less than 20%, the TIMI blood flow was grade 3, and there were no Major Adverse Cardiovascular Events during the follow-up period. MACE included cardiac death, myocardial infarction of the target vessel, or revascularization of the target lesion.
Time frame: immediately after PCI
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The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Hunan Provincial People's Hospital
Changsha, Hunan, China
the First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
the second affiliated hospital of Nanchang university
Nanchang, Jiangxi, China
China-Japan Union Hospital of Jilin University
Jilin, Jilin, China
Inner Mongolia Autonomous Region People's Hospital
Hohhot, Neimenggu, China
...and 2 more locations