Development of Novel Imaging Markers Predicting the Progression of Abdominal Aortic Aneurysm Using 3D Computed Tomography

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Abdominal aortic aneurysm
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Cook – Abdominal aortic aneurysm Cordis Corporation – Abdominal Aortic Aneurysm
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Brief Title

Development of Novel Imaging Markers Predicting the Progression of Abdominal Aortic Aneurysm Using 3D Computed Tomography

Official Title

Development of Novel Imaging Markers Predicting the Progression of Abdominal Aortic Aneurysm Using 3D Computed Tomography

Brief Summary

      Study purpose: This study will investigate anatomical factors associated with increased risk
      of major adverse aorta-related event and accelerated growth of abdominal aneurysm based on
      3-dimensional analysis of CT images.

      Study design: a multicenter single-arm prospective observational study.

      Subject: patients with small abdominal aortic aneurysm with maximal diameter of 30-50 mm
      (n=323)

      Methods: Patients diagnosed with small AAA based on CT will be enrolled after considering
      inclusion and exclusion criteria and prospectively followed clinically and with CT at 1 year.

      Primary endpoint: Major adverse aorta-related events (death, aortic rupture, or aneurysm
      growth >0.4 cm per year) at 1 year

      Secondary endpoints: 1) clinical events : death, aortic rupture, aneurysm growth >0.4 cm per
      year, surgical or endovascular repair 2) Changes in CT parameters of aneurysm: diameter,
      volume, wall shear stress

Detailed Description

      Prospective single-arm multicenter registry

Study Type

Observational

Primary Outcome

Major adverse aorta-related events

Secondary Outcome

 Number of clinical events

Condition

Abdominal Aortic Aneurysm (AAA)

Study Arms / Comparison Groups

 small AAA patients
Description:  all patients with small AAA

Publications

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

Recruitment Information

Estimated Enrollment

323

Start Date

April 2020

Completion Date

June 2022

Primary Completion Date

June 2022

Eligibility Criteria

        Inclusion Criteria:

        - abdominal aortic aneurysm with maximum diameter of 30-50 mm

        Exclusion Criteria:

          -  Age <19 years

          -  Serum Cr> 1.5mg/dL or eGFR<30 mL/min

          -  Known allergic reactions to iodine contrast media

          -  Women in pregnancy or women of childbearing age

          -  Abdominal aortic aneurysms indicated for endovascular or surgical repair (symptomatic
             aneurysm or aneurysms with diameter >5cm)

          -  Saccular type aneurysm, infected or inflammatory aneurysm

          -  Combined aortic dissection

          -  Aneurysms associated with genetic or connective tissue diseases (Marfan syndrome,
             Shprintzen-Goldberg syndrome, Loeys-Dietz syndrome, Takayasu's arteritis, Behcet's
             disease)

          -  Past history of surgical or endovascular repair of aorta

          -  Any surgical or endovascular repair planned within 1 year

          -  Life expectancy < 1 year

Gender

All

Ages

19 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, 82-2-2228-8460, [email protected]

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

Administrative Informations

NCT ID

NCT04333641

Organization ID

4-2019-0443

Responsible Party

Sponsor

Study Sponsor

Yonsei University

Study Sponsor

, ,

Verification Date

April 2020