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Based on a multi-center randomized controlled study, this research aims to evaluate the efficacy and safety of interventional therapy supported by the CorVad percutaneous left ventricular assist system (Micro-axial Flow Pump) for patients with complex coronary heart disease (CHD) complicated by ischemic left ventricular systolic dysfunction. Through a prospective, multi-center, open-label 1:1 randomized controlled trial, a total of 452 patients with severe ischemic systolic dysfunction and complex coronary lesions were enrolled. The study compared the 12-month incidence of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) between patients who received interventional therapy supported by the CorVad percutaneous left ventricular assist system in addition to the most appropriate medical therapy and those who only received the most appropriate medical therapy. This was done to test whether the interventional therapy supported by the CorVad percutaneous left ventricular assist system can improve the prognosis of patients with severe ischemic systolic dysfunction and complex coronary lesions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microaxial flow pump-supported PCI plus optimal medical therapy (OMT) arm | Experimental | Participants assigned to the intervention arm will undergo PCI supported by the micro-axial flow pump, in addition to optimal medical therapy (OMT). |
|
| Optimal medical therapy (OMT) alone arm | Other | Participants in this arms will receive guideline-directed optimal medical therapy (OMT) as determined by the heart failure team at each center. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microaxial pump-supported PCI | Device | Use CorVad left ventricular assist system (micro-axial Flow Pump) to assist PCI in complex coronary artery disease with ischemic LV dysfunction patients |
| Measure | Description | Time Frame |
|---|---|---|
| 1-year MACCE | a composite endpoint consisting of cardiovascular death, spontaneous myocardial infarction, non-fatal stroke, ischemia-driven revascularization, and readmission for heart failure | Up to 1 year after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative myocardial infarction | Up to 48h after the index PCI procedure | |
| Types 3, 4, and 5 bleeding as defined by MCS-ARC | Up to 1 year after enrollment | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kefei Dou, MD, PhD | Contact | +86-13801032912 | drdoukefei@126.com | |
| Guofeng Gao, MD | Contact | +8613811458815 | ggf03@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College | Beijing | 100037 | China |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D018487 | Ventricular Dysfunction, Left |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Optimal medical therapy (OMT) | Drug | Guideline-directed OMT will be determined by the heart failure team at each center. OMT may include antiplatelet therapy, lipid-lowering therapy, antianginal therapy, evidence-based heart failure therapy, blood pressure and glycemic control, lifestyle management, and other therapies appropriate to the patient's diagnosis and comorbidities. Evidence-based heart failure therapy includes angiotensin converting enzyme inhibitor or angiotensin receptor blocker +/- neprilysin inhibitor, beta-blocker, mineralocorticoid receptor antagonist, sodium-glucose co-transporter 2 inhibitor, and vericiguat. |
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| Severe hemolysis related to the device |
| Up to 72 hours after the implantation of the CorVad left ventricular assist system |
| Stent thrombosis | Up to 1 year after the index PCI procedure |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D018754 | Ventricular Dysfunction |