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This is a prospective, multi-center, single-group post-market study. It is planned to be carried out in about 3 clinical institutions, and a total of 60 subjects are expected to be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| microcatheter | Device | supports the insertion of the guide wire,exchange of the guide wire and the delivery of contrast media |
|
| Measure | Description | Time Frame |
|---|---|---|
| Technical success | Defined as successful guide wire passage, that is, the Pronavi Microcatheter successfully supports the guide wire through the target lesion to reach the distal true coelom. | 0 day |
| Measure | Description | Time Frame |
|---|---|---|
| Device success | Defined as delivery of the microcatheter to the designated site, assistence of guide wire into the target vessel, and successful withdrawal. | 0 day |
| Procedural success | Defined as meeting all the following criteria:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 related to the study device during the study |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Shijiazhuang People's Hospital | Shijiazhuang | Hebei | China | |||
| The Seventh People's Hospital of Zhengzhou |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 0 - 7 days |
| Device super-selective angiography (if applicable) | the microcatheter shall deliver the contrast agent to the designated location and develop | 0 day |
| Guide wire exchange supported (if applicable) | successful exchange of the guide wire | 0 day |
| Device Performance Evaluation | The investigators will evaluate the device performance according to the use and operation of the device during the procedure | 0 day |
| 0 - 7 days |
| Occurrence of other adverse events and serious adverse events during the study | 0 - 7 days |
| Zhengzhou |
| Henan |
| China |
| The Second Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi | China |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D050197 | Atherosclerosis |
| D016491 | Peripheral Vascular Diseases |