Ignite Creation Date:
2024-05-06 @ 3:19 AM
Last Modification Date:
2024-10-26 @ 11:32 AM
Study NCT ID:
NCT02266719
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-02-15
First Post:
2014-10-06
Brief Title:
Clinical Outcomes and Radiation Safety After Endovascular Repair of Complex AAAs Using Fenestrated- Branched Devices
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Clinical Outcomes and Radiation Safety After Endovascular Repair of Complex Aortic Aneurysms Using Fenestrated and Branched Devices
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-02
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 this study is to assess the clinical outcomes and radiation of the use of off-the-shelf and custom-made devices CMDs for the endovascular repair of juxtarenal suprarenal thoracoabdominal and arch aortic aneurysms in patients having appropriate anatomy The study consists of three cohorts The first 2 cohorts are the continuation of the current IDE study The first cohort is aimed to assess the use of custom-made devices CMDs for the endovascular repair of juxtarenal suprarenal and type IV thoracoabdominal aortic aneurysms in standard and high-risk patients having appropriate anatomy Fenestrated-CMD cohort The second cohort Type I-III thoracoabdominal cohort includes standard and high-risk patients with type I- III thoracoabdominal aneurysms that require the use of branchedfenestrated CMDs or in selected cases the Zenith Thoracoabdominal Branch Zenith t-Branch device Finally the third cohort the Arch cohort will include 25 high-risk patients with aortic arch aneurysms treated by patient-specific stent-grafts with one to three inner branches or a scallop
Detailed Description:
This study is a prospective single center non-randomized triple-cohort study For the Fenestrated-CMD cohort a total of 350 patients will be enrolled For the type I-III thoracoabdominal cohort a total of 250 patients will be enrolled For the Arch cohort 25 patients will be enrolled CMDs will be used primarily Off-the-shelf devices will be used in urgent cases and when the waiting period for design and manufacturing of a CMD may not be considered acceptable Staged endovascular repair will be used for type I II and III TAAAs and for concurrent arch and TAAAs unless the condition of the patient requires a single stage endovascular repair A separate subgroup analysis of patients undergoing procedures with off-the-shelf devices will be performed
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