Ignite Creation Date:
2024-05-06 @ 2:12 AM
Last Modification Date:
2024-10-26 @ 11:15 AM
Study NCT ID:
NCT01991756
Status:
UNKNOWN
Last Update Posted:
2015-01-15
First Post:
2013-11-18
Brief Title:
Safety and Performance of Altura Endograft in Abdominal Aortic Aneurysm AAA Endovascular Repair
Sponsor:
Altura Medical Inc
Organization:
Altura Medical Inc
Study Overview
Official Title:
ELEVATE International Kissing Endografts for Peripheral AAA Exclusion
Status:
UNKNOWN
Status Verified Date:
2015-01
Last Known Status:
ENROLLING_BY_INVITATION
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:
ELEVATE
Brief Summary:
The primary objective of the study is to evaluate the acute safety of deploying and implanting the Altura Endograft in the treatment of AAA in subjects who are candidates for endovascular repair
Secondary objectives are to evaluate the acute and longer-term safety and performance of the Altura Endograft through 5 years
Secondary objectives are to evaluate the acute and longer-term safety and performance of the Altura Endograft through 5 years
Detailed Description:
The primary safety endpoint of the study is freedom from Major Adverse Events MAE a composite endpoint consisting of death stroke paraplegia myocardial infarction respiratory failure renal failure bowel ischemia and blood loss 1000 mL
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