Ignite Creation Date:
2024-10-25 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06656988
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-16
Brief Title:
A Contrast Medium Sparing Strategy Using Automated CO2 Injection During PVI for Prevention of Major Adverse Kidney Events MAKE
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Contrast Medium Sparing Strategy Using Automated Carbon Dioxide Injection During PERIpheral Vascular Interventions for PREVENTion of Major Adverse Kidney Events MAKE the PeriPREVENT Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PeriPREVENT
Brief Summary:
The primary objective of the trial is to evaluate if an iodinated contrast medium sparing strategy using automated Carbon Dioxide CO2 Injection prevents Major Adverse Kidney Events up to 90 days MAKE90 in patients at moderately elevated risk for contrast-associated acute kidney injury CA-AKI undergoing infrainguinal peripheral vascular interventions PVI
Detailed Description:
PeriPREVENT is a prospective multi-centre controlled open-label 11 randomized superiority trial with two parallel groups
In the intervention group patients will undergo a routine peripheral angiographic intervention PVI using a maximally contrast medium sparing strategy with an automated CO2 injection system including iodinated CM as bailout option in case of insufficient image quality or patients intolerability of CO2 angiography
The control intervention is routine PVI using iodinated contrast media CM as standard of care
All patients are followed up until 12 months after the PVI
In the intervention group patients will undergo a routine peripheral angiographic intervention PVI using a maximally contrast medium sparing strategy with an automated CO2 injection system including iodinated CM as bailout option in case of insufficient image quality or patients intolerability of CO2 angiography
The control intervention is routine PVI using iodinated contrast media CM as standard of care
All patients are followed up until 12 months after the PVI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None