Viewing Study NCT04216433



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Last Modification Date: 2024-10-26 @ 1:25 PM
Study NCT ID: NCT04216433
Status: COMPLETED
Last Update Posted: 2021-12-10
First Post: 2019-08-12

Brief Title: A Large Surgical Registry for Abdominal Aortic Aneurysms AAA
Sponsor: Methodist Health System
Organization: Methodist Health System

Study Overview

Official Title: A Large Surgical Registry for Abdominal Aortic Aneurysms AAA
Status: COMPLETED
Status Verified Date: 2021-12
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 andor 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 800000 patients in the US

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