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This study will collect initial clinical data on the CSI pVAD system to inform device design and finalization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CSI pVAD | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CSI pVAD system | Device | The CSI percutaneous ventricular assist device (pVAD) is being investigated as a temporary left ventricular system intended to support and/or provide hemodynamic stability during high-risk percutaneous coronary interventions. |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural success | Delivery of the device to the correct anatomical position, successful operation and removal of the CSI pVAD system | Intraprocedural |
| Intraprocedural Major Device-Related Adverse Events | Composite incidence of:
| 24-hours Post-Index Procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeff Chambers, MD | Abbott Medical Devices | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tbilisi Heart & Vascular | Tbilisi | Georgia |
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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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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |