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Completed

NCT Number: NCT02016131

CQDSA in Evaluation of Prognosis After EVAR

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongshan Hospital

Shanghai, 200032, China

About this study

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.

  • 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.
  • ROI Peak/Ref Peak. It is the ratio of intensity peak between the endoleak and the reference in the aorta.
  • ROI TTP (Time to peak). Peak time of ROI in the vicinity of endoleak entry.
  • 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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. ROI Peak/Ref Peak

    Time frame: 15 seconds

    It is the ratio of intensity peak between the endoleak and the reference in the aorta.

  3. ROI TTP (Time to peak)

    Time frame: 15 seconds

    Peak time of ROI in the vicinity of endoleak entry

  4. 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.

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Collaborators

  • Siemens Ltd., China, Shanghai, China.

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Dec 19, 2013
Registry last updated
Aug 21, 2025

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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