Ignite Creation Date:
2024-05-06 @ 5:37 PM
Last Modification Date:
2024-10-26 @ 2:32 PM
Study NCT ID:
NCT05378347
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2022-05-12
Brief Title:
Endurant Stent Graft System vs Excluder Endoprothesis ADVANCE Trial
Sponsor:
Medtronic Cardiovascular
Organization:
Medtronic Cardiovascular
Study Overview
Official Title:
Endurant Stent Graft System vs Excluder Endoprothesis A Global Prospective Randomized Clinical Trial in Sac Regression
Status:
RECRUITING
Status Verified Date:
2024-09
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:
ADVANCE
Brief Summary:
The purpose of this trial is to generate clinical evidence related to key performance outcomes of Endurant IIIIs Stent Graft Systems verses Gore Excluder Excluder Conformable AAA Endoprosthesis in subjects with Abdominal Aortic Aneurysms Subjects are randomized and imaging collected at all follow-up time points to assess the primary endpoint
Detailed Description:
This is a post-market prospective interventional global multi-center randomized dual-arm clinical trial The primary objective of this trial is to evaluate sac regression outcomes of the Medtronic Endurant IIIIs Stent Graft System and Gore ExcluderExcluder Conformable AAA Endoprosthesis in standard EVAR subjects Subjects are randomized on a 11 basis to receive EVAR with either a Medtronic Endurant IIIIs Stent Graft Systems or Gore Excluder Excluder Conformable AAA Endoprosthesis Data is collected pre- and post-procedure at discharge at 30 days and once a year until the 5-year follow-up is completed An estimate of 550 subjects minimum 500 are enrolled at up to 100 sites globally with the potential to extend enrollment up to 900 subjects based on predictive probability analysis to adequately achieve either non-inferiority or superiority for the primary endpoint
Product Names
Medtronic Endurant IIIIs Stent Graft System
Gore Excluder andor Gore Excluder Conformable AAA Endoprosthesis Imaging is collected for all follow-up time points and are evaluated by a core lab for the key primary and secondary objectives
Product Names
Medtronic Endurant IIIIs Stent Graft System
Gore Excluder andor Gore Excluder Conformable AAA Endoprosthesis Imaging is collected for all follow-up time points and are evaluated by a core lab for the key primary and secondary objectives
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None