Ignite Creation Date:
2024-05-06 @ 10:10 AM
Last Modification Date:
2024-10-26 @ 12:26 PM
Study NCT ID:
NCT03187522
Status:
TERMINATED
Last Update Posted:
2021-03-03
First Post:
2017-06-11
Brief Title:
An European Union EU Post-Approval Registry of the TREO Stent-Graft
Sponsor:
Bolton Medical
Organization:
Bolton Medical
Study Overview
Official Title:
An EU Post-Approval Registry of the TREO Stent-Graft for Patients With Infrarenal Abdominal Aortic Aneurysms
Status:
TERMINATED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Post Market Study terminated early due to the launch and subsequent incorporation of the study into the Terumo Aortic Endovascular Registry TiGER-001
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an EU sponsored trial and independent of the US trial registered under Clinicaltrialsgov ID NCT02009644
The purpose of this registry is to gather clinical data on the safety and performance of the TREO Stent-Graft in patients with infrarenal abdominal aortic aneurysms The registry is part of TREOs EU post-market surveillance plan providing long-term systematic clinical follow-up
The purpose of this registry is to gather clinical data on the safety and performance of the TREO Stent-Graft in patients with infrarenal abdominal aortic aneurysms The registry is part of TREOs EU post-market surveillance plan providing long-term systematic clinical follow-up
Detailed Description:
This is a prospective multicenter post-market clinical follow-up non-randomized registry of the TREO Stent-Graft Subjects diagnosed with infrarenal aortic aneurysms and treated with the TREO Stent-Graft or TREO aorto-uni-iliac AUI device can be included into the registry Pre-procedure baseline data will be gathered as well as post-procedure assessments prior to hospital discharge and one to three months and 1 2 3 4 and 5-year post-implantation
The objective of the registry is to assess the clinical results and health economics of the TREO device in a real-world population of patients with infrarenal abdominal aortic aneurysms AAA
The objective of the registry is to assess the clinical results and health economics of the TREO device in a real-world population of patients with infrarenal abdominal aortic aneurysms AAA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None