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OpenTrials
Completed

NCT Number: NCT04216433

A Large Surgical Registry for Abdominal Aortic Aneurysms (AAA)

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Methodist Health System

Dallas, Texas, 75203, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women who received endovascular or open AAA repair (primary/secondary procedure codes: ICD-9=38.44 for open, ICD-9=39.71 for endovascular repair) at any of the 138 Dallas-Fort Worth area hospitals that report AAA data to the DFWHC Data Initiative.
  • patients age 50 years old or older.

Exclusion criteria

  • Patients with HIV and substance abuse
  • Patients with substance abuse
  • Patients > 50 years old

Treatment and study plan

endovascular surgery

Procedure

an innovative, less invasive procedure used to treat problems affecting the blood vessels, such as an aneurysm, which is a swelling or "ballooning" of the blood vessel. The surgery involves making a small incision near each hip to access the blood vessels.

Primary outcomes

  1. Overall survival

    Time frame: 2000 to 2009

    time (in days) from first AAA surgery to death (any cause)

  2. Time to re-operation

    Time frame: 2000 to 2009

    time (in days) from first AAA surgery to AAA re-operation

  3. Time to rupture

    Time frame: 2000 to 2009

    time (in days) from first AAA surgery to AAA rupture

Secondary outcomes

  1. Type of AAA surgery

    Time frame: day of surgery

    either open or endovascular AAA surgery

Sponsors and collaborators

Lead sponsor

Methodist Health System

Other

Registry information

Acronym: AAA

Important dates

Study start
2012
Primary completion
2021
Study completion
2021
First posted
Jan 2, 2020
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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