Ignite Creation Date:
2024-05-06 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 2:30 PM
Study NCT ID:
NCT05334784
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-12-15
First Post:
2022-03-28
Brief Title:
Impella ECP Study ECP Study and Impella ECP Continued Access Protocol
Sponsor:
Abiomed Inc
Organization:
Abiomed Inc
Study Overview
Official Title:
Use of the Impella ECP in Patients Undergoing an Elective or Urgent High-Risk Percutaneous Coronary Intervention Impella ECP Continued Access Protocol
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-07
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:
None
Brief Summary:
The Impella ECP Study is a prospective multi-center single-arm study evaluating the rate of major adverse cardiovascular and cerebrovascular events MACCE with the Impella ECP device in adult patients undergoing elective or urgent high-risk percutaneous coronary intervention
The above applies to Impella ECP Continued Access Protocol
The above applies to Impella ECP Continued Access Protocol
Detailed Description:
This is a prospective multi-center single-arm study evaluating the major adverse cardiovascular and cerebrovascular event MACCE rate of the Impella ECP device in adult patients undergoing elective or urgent high-risk percutaneous coronary intervention HRPCI Additionally this study will evaluate safety related to Impella ECP-related major vascular complications and Impella ECP-related major bleeding Finally this study will evaluate secondary endpoints including the occurrence of major hemolysis aortic valve injury escalation of care to Impella CP and the length of hospital stay
Investigational device products include Impella ECP pump system a percutaneous transvalvular micro-axial blood pump 9Fr introducer sheath and the automated Impella controller AIC with revised console software to allow control of the Impella ECP
Study flow Following informed consent subjects eligible for a HRPCI that meet all of the inclusion and none of the exclusion criteria will be enrolled into the Study Subjects will undergo Impella ECP placement through a femoral sheath following crimping of the Impella ECP The intended coronary intervention will be performed with the mechanical circulatory support provided by the Impella ECP Once the procedure is completed the device is weaned and removed Subjects will be followed for 30 days Subjects will be treated based on the contemporary AHAACCSCAI practice guidelines throughout the duration of the Study
A sample size of two hundred seventeen 217 subjects with 30-day follow-up is needed for 90 power at a one-sided 005 significance level Assuming 15 loss-to-follow-up up to two hundred fifty-six 256 subjects will be enrolled Safety endpoints will be presented as summary statistics without formal hypothesis testing The MACCE rate will be assessed against the PG of 244 at one-sided 5 significance level
Impella ECP Continued Access Protocol
Description Investigational device and study flow remains the same as above
A sample size up to three hundred 300 subjects will be enrolled at up to 25 sites Sites must have been activated in the Pivotal to be eligible for the Continued Access Protocol
Investigational device products include Impella ECP pump system a percutaneous transvalvular micro-axial blood pump 9Fr introducer sheath and the automated Impella controller AIC with revised console software to allow control of the Impella ECP
Study flow Following informed consent subjects eligible for a HRPCI that meet all of the inclusion and none of the exclusion criteria will be enrolled into the Study Subjects will undergo Impella ECP placement through a femoral sheath following crimping of the Impella ECP The intended coronary intervention will be performed with the mechanical circulatory support provided by the Impella ECP Once the procedure is completed the device is weaned and removed Subjects will be followed for 30 days Subjects will be treated based on the contemporary AHAACCSCAI practice guidelines throughout the duration of the Study
A sample size of two hundred seventeen 217 subjects with 30-day follow-up is needed for 90 power at a one-sided 005 significance level Assuming 15 loss-to-follow-up up to two hundred fifty-six 256 subjects will be enrolled Safety endpoints will be presented as summary statistics without formal hypothesis testing The MACCE rate will be assessed against the PG of 244 at one-sided 5 significance level
Impella ECP Continued Access Protocol
Description Investigational device and study flow remains the same as above
A sample size up to three hundred 300 subjects will be enrolled at up to 25 sites Sites must have been activated in the Pivotal to be eligible for the Continued Access Protocol
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None