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The purpose of this prospective, multicenter, randomized controlled clinical trial is to evaluate the effectiveness of the transcatheter left ventricular assist system (Ventiflow LP) in providing circulatory support to patients during high-risk PCI procedures compared to veno-arterial extracorporeal membrane oxygenation (VA-ECMO).The participants will be randomly assigned to the experimental group or the control group after enrollment, and will undergo percutaneous coronary intervention(PCI) with support from Ventiflow LP or VA-ECMO respectively. All participants need to undergo a 3-month follow-up after operative.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group(Ventiflow LP) | Experimental |
| |
| Control Group(VA-ECMO) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous left ventricular assist device(Ventiflow LP) | Device | The PCI will be completed with the support of percutaneous left ventricular assist device(Ventiflow LP). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of major adverse events within 30 days post-operation. | Major adverse events are defined as death, stroke, myocardial infarction, revascularization, rehospitalization due to cardiovascular reasons, bleeding types 3, 4, 5 defined by mechanical circulatory support academic research consortium (MCS-ARC) , acute kidney injury, serious device-related adverse events, cardiopulmonary resuscitation. | 30 days post-operation |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of major adverse events within 90 days post-operation. | 90 days post-operation | |
| Incidence of major adverse cardiovascular and cerebrovascular events (MACCE) at 30 days post-operation. | MACCE is defined as all-cause mortality, myocardial infarction, stroke, and any subsequent revascularization procedures . |
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Inclusion Criteria:
18 Years to 90 Years
The cardiac team determined that the subject needs coronary artery revascularization, but there is a higher risk of CABG, or the subject refuses to accept CABG. After comprehensive evaluation by the cardiac team, it was determined that the subjects could benefit from PCI
The subject is diagnosed with acute or chronic coronary syndrome, and
Informed consent
The participant meets all the above clinical inclusion criteria and must comply with at least one of the following imaging criteria.
1. At least two coronary artery CTOs (diameter of occluded artery ≥ 2.5mm) 2. Unprotected left main coronary artery disease, and meeting one or more complex operating standards 3. Three-vessel disease and meeting two or more complex operating standards
Complex operations are defined as:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yujie Zhou, MD | Contact | 086-13901330652 | azzyj12@163.com | |
| Xiaoshen Yan | Contact | 86-0512-87662295 | kevin.yan@hearthillmedical.com |
| Name | Affiliation | Role |
|---|---|---|
| Yujie Zhou, MD | Beijing Anzhen Hospital | Study Chair |
| Yong He, MD | West China Hospital | Study Chair |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| VA-ECMO | Device | The PCI will be completed with the support of Veno-arterial extracorporeal membrane oxygenation (VA-ECMO). |
|
| 30 days post-operation |
| Incidence of major adverse cardiovascular and cerebrovascular events (MACCE) at 90 days post-operation. | MACCE is defined as all-cause mortality, myocardial infarction, stroke, and any subsequent revascularization procedures . | 90 days post-operation |
| Success rate of hemodynamic support during device use | definition of successful hemodynamic support: successful delivery and initiation of the device, no hemodynamic deregulation occurs during the device support period (haemodynamic derangement refers to: mean arterial pressure(MAP ) less than 60 mmHg for more than 10 minutes and requires additional vasoactive drug therapy) | 90 days post-operation |
| The success rate of percutaneous coronary intervention(PCI) | The success rate of PCI is defined as: residual stenosis < 30% after stent implantation or < 50% after balloon angioplasty, or thrombolysis in myocardial infarction(TIMI) flow grade 3. | 90 days post-operation |
| Complete revascularization rate | Complete revascularization rate is defined as: residual SYNTAX score ≤8 | Immediately after the intervention |
| Change in creatinine clearance | Baseline to 48 hours postoperation and 30 days post-operation |
| The change in left ventricular ejection fraction (LVEF) compared to baseline | Baseline to 30 days post-operation and 90 days post-operation |
| The change in New York heart association(NYHA) classification compared to baseline | The NYHA classification of heart function consists of four levels, ranging from I to IV, with heart function progressively deteriorating. | 30 days post-operation, 90 days post-operation |
| Length of hospital stay within 30 days post-operation | 30 days post-operation |
| Length of intensive care unit(ICU)/(coronary care unit)CCU stay within 30 days post-operation | 30 days post-operation |
| Success rate of device operation | The system has delivered to the designated position and completed the pump start-up without any device failure. | 30 days post-operation |
| Usage time of research device | The time from the start to the stop of the research device. | 30 days post-operation |
| Device performance evaluation | The operator scores the device after use, with 5 being the best and 1 being the worst. | Intraoperation |
| The failure rate of the device | The failure rate of the device is defined as any component of the research equipment (Ventiflow LP or ECMO) system that is unable to operate according to its designed performance specifications . | Intraoperation |
| Incidence of serious adverse events | Incidence of serious adverse events: Serious adverse events refer to those that occur during the clinical trial process and result in death or a significant deterioration in health status, including fatal diseases or injuries, permanent impairment of bodily structure or function, and events that require medical or surgical intervention to prevent permanent impairment of bodily structure or function, among others. | 90 days post-operation |
| The incidence of serious adverse events | The incidence of serious adverse events related to medical devices: including but not limited to cardiac structural damage, severe limb ischemia (pallor, pulselessness, and necrosis), infections, damage to the aorta and aortic valve, hemolysis, complications requiring surgical intervention, and events leading to subject mortality, permanent or severe disability, significantly prolonged hospitalization, or the need for surgical intervention . | 90 days post-operation |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |