NCT04216433

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
394

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
7.6 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2019

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 2, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

March 23, 2026

Status Verified

September 1, 2024

Enrollment Period

9.5 years

First QC Date

August 12, 2019

Last Update Submit

March 19, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Overall survival

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

    2000 to 2009

  • Time to re-operation

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

    2000 to 2009

  • Time to rupture

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

    2000 to 2009

Secondary Outcomes (1)

  • Type of AAA surgery

    day of surgery

Interventions

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.

Eligibility Criteria

Age50 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Methodist Health System

Dallas, Texas, 75203, United States

Location

Study Officials

  • Robert Feldtman, MD

    DFW Vascular Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2019

First Posted

January 2, 2020

Study Start

January 1, 2012

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

March 23, 2026

Record last verified: 2024-09

Locations