Ignite Creation Date:
2024-05-06 @ 7:10 AM
Last Modification Date:
2024-10-26 @ 11:45 AM
Study NCT ID:
NCT02489539
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-04
First Post:
2015-06-22
Brief Title:
Assessment of the GORE EXCLUDER Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms
Sponsor:
WLGore Associates
Organization:
WLGore Associates
Study Overview
Official Title:
Assessment of the GORE EXCLUDER Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
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:
None
Brief Summary:
The purpose of the study is to assess the safety and effectiveness of the GORE EXCLUDER Conformable AAA Endoprosthesis to treat an infrarenal aneurysm located in the abdominal aorta Performance of the GORE EXCLUDER Conformable AAA Endoprosthesis will be judged by separate performance goals
Detailed Description:
The study design is a prospective nonrandomized international multicenter study comprised of two parallel substudies The total subject population is 175 subjects with 80 subjects assigned to the Short Neck Substudy and 95 subjects to the High Neck Angulation Substudy
This clinical study will include up to fifty-six sites in the US Each enrolled subject will undergo periodic follow-up evaluations involving physical exams and contrast-enhanced computed tomography CT scans at specific protocol-defined intervals for a period of five years following the GORE EXCLUDER Conformable AAA Endoprosthesis implant Each Substudy will be evaluated and reported independently from each other according to the Safety and Effectiveness Endpoints No comparative analyses between these substudies are planned
This clinical study will include up to fifty-six sites in the US Each enrolled subject will undergo periodic follow-up evaluations involving physical exams and contrast-enhanced computed tomography CT scans at specific protocol-defined intervals for a period of five years following the GORE EXCLUDER Conformable AAA Endoprosthesis implant Each Substudy will be evaluated and reported independently from each other according to the Safety and Effectiveness Endpoints No comparative analyses between these substudies are planned
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?:
None
Is an FDA AA801 Violation?:
None