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This study aims to evaluate the safety and effectiveness of the VentriCure interventional left ventricular assist system for short-term ventricular support during high-risk percutaneous coronary intervention (HRPCI) in non-emergent, hemodynamically stable coronary artery disease patients via a prospective, multi-center, randomized controlled clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VentriCure | Experimental | The VentriCure interventional left ventricular assist system provides hemodynamics support for intraoperative protection during high-risk percutaneous coronary intervention. |
|
| ECMO | Active Comparator | Subjects with coronary artery disease receiving high-risk PCI will be supported by the Extracorporeal Membrane Oxygenation System during the procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VentriCure Interventional left ventricular assist system | Device | The VentriCure interventional left ventricular assist system provides hemodynamics support for intraoperative protection during high-risk percutaneous coronary intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of major adverse events at 30 days post-PCI | Major adverse events were defined as follows: death, new myocardial infarction, stroke, target-vessel revascularization, major bleeding. Calculation formula: 30-day MAE rate = Number of subjects experiencing any MAE event within 30 days post-PCI ÷ Total number of subjects × 100% | 30 days post-PCI |
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Inclusion Criteria:
(1) Coronary Artery Disease and left ventricular ejection fraction ≤35%; (2) Coronary Artery Disease and left ventricular ejection fraction ≤40% and severe heart failure; 4. PCI was required for imaging diagnosis; 5. Patient willing and able to comply with protocol requirements and accept clinical follow-up; able to understand study purpose and sign informed consent.
Exclusion Criteria:
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| ECMO | Device | Subjects with coronary artery disease receiving high-risk PCI will be supported by the Extracorporeal Membrane Oxygenation System during the procedure. |
|
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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