Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2026-02-12 @ 11:48 AM
Study NCT ID:
NCT01151020
Status:
COMPLETED
Last Update Posted:
2021-01-22
First Post:
2010-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
TX2® Low Profile TAA Endovascular Graft
Sponsor:
Cook Research Incorporated
Organization:
Study Overview
Official Title:
Zenith® TX2® Low Profile TAA Endovascular Graft Clinical Study
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT02471781
Has Expanded Access, NCT# Status:
APPROVED_FOR_MARKETING
Acronym:
TX2® LP
Brief Summary:
The Zenith® TX2® Low Profile TAA Endovascular Graft study is a clinical trial approved by US FDA to evaluate the safety and effectiveness of the Zenith® TX2® Low Profile TAA Endovascular Graft indicated for the treatment of patients with aneurysms/ulcers of the descending thoracic aorta having vessel structure suitable for repair.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: