Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06373120
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-03-11
Brief Title:
Interventional Ventricular Assist System for PCI in CHIP Patients
Sponsor:
Xijing Hospital
Organization:
Xijing Hospital
Study Overview
Official Title:
Interventional Ventricular Assist System for PCI in Complicated and High-risk Patient a Prospective Multicenter Randomized Trial
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REC-CHIPMCS
Brief Summary:
In patients with complex coronary artery disease CAD determining the optimal revascularization strategy percutaneous coronary intervention PCI or coronary artery bypass grafting CABG remains a challenge These high-risk patients pose an extreme surgical risk However with the development of new interventional techniques and materials PCI is a good alternative to CABG and is referred to as complex high-risk indicated PCI CHIP
During CHIP hemodynamics can deteriorate because of temporary complete coronary occlusion or profound myocardial ischemia This could result in loss of cardiac output and hemodynamics collapse Mechanical support during CHIP facilitates native cardiac function by achieving a stable hemodynamic state to withstand repetitive derangements such as ischemia caused by prolonged and repeated balloon inflations and resume original cardiac function immediately postprocedure or shortly thereafter
There are several mechanical circulatory support MCS systems available ie intra-aortic balloon counterpulsation IABP Impella TandemHeart and veno-arterial extracorporeal membrane oxygenation VA-ECMO These MCS have been widely studied in patients with acute myocardial infarction MI complicated by cardiogenic shock and showed conflicting results However studies regarding the use of MCS in the setting of CHIP are much less abundant and no randomized study has compared Impella with VA-ECMO in CHIP patients
The aim of the study is to evaluate the effectiveness of interventional ventricular assist system CorVad compared to the venoarterial extracorporeal membrane oxygenation VA-ECMO system in providing circulatory support for complicated and high-risk patient with indications for PCI
During CHIP hemodynamics can deteriorate because of temporary complete coronary occlusion or profound myocardial ischemia This could result in loss of cardiac output and hemodynamics collapse Mechanical support during CHIP facilitates native cardiac function by achieving a stable hemodynamic state to withstand repetitive derangements such as ischemia caused by prolonged and repeated balloon inflations and resume original cardiac function immediately postprocedure or shortly thereafter
There are several mechanical circulatory support MCS systems available ie intra-aortic balloon counterpulsation IABP Impella TandemHeart and veno-arterial extracorporeal membrane oxygenation VA-ECMO These MCS have been widely studied in patients with acute myocardial infarction MI complicated by cardiogenic shock and showed conflicting results However studies regarding the use of MCS in the setting of CHIP are much less abundant and no randomized study has compared Impella with VA-ECMO in CHIP patients
The aim of the study is to evaluate the effectiveness of interventional ventricular assist system CorVad compared to the venoarterial extracorporeal membrane oxygenation VA-ECMO system in providing circulatory support for complicated and high-risk patient with indications for PCI
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None