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This is a prospective, multi-center, single-group study aims to evaluate the safety and efficacy of Alveo HP Balloon Dilatation Catheter for balloon dilatation of coronary artery stenosis. Pre-dilation with Alveo balloon dilatation catheter followed by conventional PCI, and follow-up will be carried out. During the trial, the enrollment, treatment and follow-up of the subjects will be recorded, and the safety and efficacy of the investigational device will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alveo balloon dilatation catheter | Experimental | Subjects who meet the inclusion criteria and agree to participate in the study will be enrolled and undergo a planned percutaneous coronary intervention with Alveo balloon dilatation catheter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alveo HP Balloon Dilatation Catheter | Device | Alveo HP Balloon is intended for dilatation of stenosis in the coronary artery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Procedural Success Rate | Defined as meeting all the following criteria:
| 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Device Success Rate | Defined as meeting all the following criteria:
| 0 day |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of major adverse cardiac events (MACE) during the study. | Major adverse cardiac events (MACE) are defined as cardiac death, myocardial infarction, and target lesion revascularization (TLR). | 0 - 7 days |
| Adverse events and serious adverse events rate |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Seventh People's Hospital of Zhengzhou | Zhenzhou | Henan | China | |||
| Renmin Hospital of Wuhan University Hubei General Hospital |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Device Performance Evaluation | The investigators will evaluate the device performance according to the use and operation of the device during the procedure. Evaluate performance of balloon catheter delivery, inflation, deflation, and withdrawal, etc. There are 5 levels ranging from poor to excellent, higher scores indicate better performance. | 0 day |
Adverse events and serious adverse events related to the study device during the study. |
| 0 - 7 days |
| Other Adverse events and serious adverse events rate | Occurrence of other adverse events and serious adverse events | 0 - 7 days |
| Wuhan |
| Hubei |
| China |
| Shanxi Cardiovascular Hospital | Taiyuan | Shanxi | China |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |