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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravascular high-pressure cutting balloon catheter | Active Comparator |
| |
| Boston Scientific Corporation | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCI | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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% | immediately after PTCA |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | immediately after PCI |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital of USTC | Hefei | Anhui | China | |||
| Zhongshan Hospital Affiliated to Xiamen University |
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| ID | Term |
|---|---|
| D058226 | Plaque, Atherosclerotic |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Xiamen |
| Fujian |
| China |
| Daqing Oilfield General Hospital | Daqing | Heilongjiang | China |
| 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 City | Jilin | China |
| Inner Mongolia Autonomous Region People's Hospital | Hohhot | Neimenggu | China |
| First Affiliated Hospital of the Air Force Medical University | Xi'an | Shaanxi | China |
| West China Hospital of Sichuan University | Chengdu | Sichuan | China |