Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-02-28 @ 4:57 AM
Study NCT ID:
NCT04216433
Status:
COMPLETED
Last Update Posted:
2024-11-20
First Post:
2019-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Large Surgical Registry for Abdominal Aortic Aneurysms (AAA)
Sponsor:
Methodist Health System
Organization:
Study Overview
Official Title:
A Large Surgical Registry for Abdominal Aortic Aneurysms (AAA)
Status:
COMPLETED
Status Verified Date:
2024-09
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:
AAA
Brief Summary:
In the spirit of improving patient safety and quality of healthcare in our region, the Dallas-Fort Worth Hospital Council Education and Research Foundation (Foundation) and Baylor Research Institute sought and obtained federal funding support (AHRQ grant) to develop an Abdominal Aortic Aneurism (AAA) surgery registry in North Texas. Participating centers will directly benefit from this project and will have access to a de-identified version of the registry data through their collaboration. These data may be used for quality improvement initiatives and/or to conduct your own research. In summary, this effort represents a substantial investment (with no costs to facilities) in improving outcomes for patients with AAA.
Detailed Description:
Currently, little is known about who receives which type of surgery. What data are available are largely from single-centre studies, with study populations of a few hundred to a thousand patients, comparing outcomes for open and endovascular repair and collecting patient characteristic data largely for risk adjustment. Data on endovascular vs open AAA repair from the population-based registry will provide important information regarding the current use of these two treatment strategies, as well as allowing comparison of long-term outcomes for each according to different patient characteristics.
The proposed registry has the potential to provide means for internal quality assessment for the participating institutions. The de-identified registry will be made available to researchers at their request. This registry, focusing on AAA in the Dallas-Fort Worth metroplex, will provide data with the potential to improve treatments for more than 800,000 patients in the US.
The proposed registry has the potential to provide means for internal quality assessment for the participating institutions. The de-identified registry will be made available to researchers at their request. This registry, focusing on AAA in the Dallas-Fort Worth metroplex, will provide data with the potential to improve treatments for more than 800,000 patients in the US.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: