Ignite Creation Date:
2024-05-06 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04697784
Status:
RECRUITING
Last Update Posted:
2023-09-29
First Post:
2020-12-10
Brief Title:
Post-Approval Study of the TREO Abdominal Stent-Graft System
Sponsor:
Bolton Medical
Organization:
Bolton Medical
Study Overview
Official Title:
Post-Approval Study of the TREO Abdominal Stent-Graft System P190015 in Patients With Infrarenal Abdominal Aortic and Aorto-iliac Aneurysms
Status:
RECRUITING
Status Verified Date:
2023-09
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:
TREO PAS
Brief Summary:
The purpose of this study is to determine the long-term performance of the TREO Abdominal Stent-Graft as a treatment for patients with Infrarenal Abdominal Aortic Aneurysms or Aorto-iliac Aneurysms
Detailed Description:
This is a prospective multi-center non-randomized single-arm post-market non-interventional study of treatment with the TREO Abdominal Stent-Graft in subjects with Infrarenal Abdominal Aortic Aneurysms or Aorto-iliac Aneurysms The study will include a minimum of 300 subjects treated with the TREO Abdominal Stent-Graft at up to 55 investigational sites in the US
The primary objective is the collection of real world safety and effectiveness outcomes of the TREO Abdominal Stent-Graft System in an all-comers population eligible for the endovascular treatment of AAA in routine clinical practice with emphasis on subjects that experience a device stent-strut or barb fracture
The primary objective is the collection of real world safety and effectiveness outcomes of the TREO Abdominal Stent-Graft System in an all-comers population eligible for the endovascular treatment of AAA in routine clinical practice with emphasis on subjects that experience a device stent-strut or barb fracture
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