A Large Surgical Registry for Abdominal Aortic Aneurysms (AAA)

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Abdominal aortic aneurysm
Related Access Program
Cook – Abdominal aortic aneurysm Cordis Corporation – Abdominal Aortic Aneurysm
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Brief Title

A Large Surgical Registry for Abdominal Aortic Aneurysms (AAA)

Official Title

A Large Surgical Registry for Abdominal Aortic Aneurysms (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.

Study Type

Observational [Patient Registry]

Primary Outcome

Overall survival

Secondary Outcome

 Type of AAA surgery

Condition

Abdominal Aortic Aneurism

Intervention

endovascular surgery

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

6500

Start Date

January 2012

Completion Date

January 2025

Primary Completion Date

January 2023

Eligibility Criteria

        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

Gender

All

Ages

50 Years - N/A

Contacts

Robert Feldtman, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT04216433

Organization ID

2012.00.591.A

Responsible Party

Sponsor

Study Sponsor

Methodist Health System

Study Sponsor

Robert Feldtman, MD, Principal Investigator, DFW Vascular Group

Verification Date

June 2019