CQDSA in Evaluation of Prognosis After EVAR

May 26, 2015 updated by: Zhenyu Shi, Shanghai Zhongshan Hospital

Application of Color-coded Quantitative Digital Subtraction Angiography in Evaluation of Prognosis After Endovascular Repairment of Abdominal Aortic Aneurysm

Re-hospitalization or re-intervention is sometimes necessary to treat type I and type III endoleaks after EVAR for its persistent increasing of pressure in aneurysm lumen. Color-coded quantitative digital subtraction angiography (CQDSA) provides an easy and quick way to post-process the traditional digital subtraction angiography (DSA) which converts the peak time of the maximal contrast medium intensity into a single polychromatic image. With the help of CQDSA, a quantitative evaluation of the endoleak hemodynamics and a risk analysis of the type I or type III endoleak could be performed during the EVAR procedure. This approach may offer an objective assessment of the needs for immediate re-intervention, conservative therapy or treatment endpoint in the future.

Study Overview

Status

Completed

Conditions

Detailed Description

Intra-procedural DSA series are transferred to a research workstation to generate the color-coded images and make quantitative measurements. Region of interest (ROI) measurements are performed equivalently in the endoleak and the aorta after the image generation. There are three kinds of ROIs including a small circle area with the shortest time to peak, a circle area with peak contrast intensity and the whole endoleak area. The ROI and a reference at the same latitude within the aorta are selected to undergo measurement which reflected the endoleak hemodynamics of the endoleak to the utmost extent.

The following parameters will be acquired through the CQDSA for analysis.

  1. Time-versus-ROI contrast intensity graph. The graph contains one endoleak ROI flow curve and one reference aortic flow curve (Ref). The x-axis shows time from 0 second to the maximum frame time of the image. The y-axis shows the sum of pixel intensities, namely total contrast, representing the contrast concentration within the ROI.
  2. ROI Peak/Ref Peak. It is the ratio of intensity peak between the endoleak and the reference in the aorta.
  3. ROI TTP (Time to peak). Peak time of ROI in the vicinity of endoleak entry.
  4. ROI AUC/Ref AUC. Area under curve (AUC) is calculated through Time-versus-ROI contrast intensity graph. The parameter here is the ratio of ROI AUC in endoleak to the reference.

Study Type

Observational

Enrollment (Actual)

49

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200032
        • Zhongshan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who present type I endoleak after EVAR for AAA.

Description

Inclusion Criteria:

  • Patients who present type I or/and type III endoleak after EVAR for AAA and complete at least 3 months' follow up.

Exclusion Criteria:

  • Patients who

    1. undergo surgeries which involve the segment covered by EVAR;
    2. present connective tissue disease, such as Marfan's Syndrome or vasculitis.
    3. present abdominal aortic dissection.
    4. present AAA rupture.
    5. die from non aneurysm-reltated reasons or are lost during follow up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
none endoleak events
Patients who have no further endoleaks related adverse events including aneurysm enlargement and rupture or persistent endoleaks.
Endoleak events
Patients who undergo endoleaks related adverse events or persistent endoleaks during follow up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time-versus-ROI contrast intensity graph.
Time Frame: 15 seconds
The graph contains one endoleak ROI flow curve and one reference aortic flow curve (Ref). The x-axis shows time from 0 second to the maximum frame time of the image. The y-axis shows the sum of pixel intensities, namely total contrast, representing the contrast concentration within the ROI.
15 seconds
ROI Peak/Ref Peak
Time Frame: 15 seconds
It is the ratio of intensity peak between the endoleak and the reference in the aorta.
15 seconds
ROI TTP (Time to peak)
Time Frame: 15 seconds
Peak time of ROI in the vicinity of endoleak entry
15 seconds
ROI AUC/Ref AUC
Time Frame: 15 seconds
Area under curve (AUC) is calculated through Time-versus-ROI contrast intensity graph. The parameter here is the ratio of ROI AUC in endoleak to the reference.
15 seconds

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Collaborators

Siemens Ltd., China, Shanghai, China.

Investigators

  • Study Chair: Weiguo Fu, MD, Shanghai Zhongshan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

December 14, 2013

First Submitted That Met QC Criteria

December 14, 2013

First Posted (Estimate)

December 19, 2013

Study Record Updates

Last Update Posted (Estimate)

May 28, 2015

Last Update Submitted That Met QC Criteria

May 26, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CQDSA_EVAR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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