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CQDSA in Evaluation of Prognosis After EVAR

Sponsor
Shanghai Zhongshan Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02016131
Collaborator
Siemens Ltd., China, Shanghai, China. (Other)
49
Enrollment
1
Location
37.9
Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    49 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Application of Color-coded Quantitative Digital Subtraction Angiography in Evaluation of Prognosis After Endovascular Repairment of Abdominal Aortic Aneurysm
    Study Start Date :
    Jan 1, 2012
    Actual Primary Completion Date :
    Sep 1, 2014
    Actual Study Completion Date :
    Mar 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Time-versus-ROI contrast intensity graph. [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 [15 seconds]

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

    3. ROI TTP (Time to peak) [15 seconds]

      Peak time of ROI in the vicinity of endoleak entry

    4. ROI AUC/Ref AUC [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zhongshan Hospital Shanghai China 200032

    Sponsors and Collaborators

    • Shanghai Zhongshan Hospital
    • Siemens Ltd., China, Shanghai, China.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Zhenyu Shi, Associate Prof., Shanghai Zhongshan Hospital
    ClinicalTrials.gov Identifier:
    NCT02016131
    Other Study ID Numbers:
    • CQDSA_EVAR
    First Posted:
    Dec 19, 2013
    Last Update Posted:
    May 28, 2015
    Last Verified:
    May 1, 2015
    Keywords provided by Zhenyu Shi, Associate Prof., Shanghai Zhongshan Hospital
    endoleak
    EVAR
    AAA
    CQDSA
    Additional relevant MeSH terms:
    Aneurysm
    Aortic Aneurysm
    Aortic Aneurysm, Abdominal
    Endoleak

    Study Results

    No Results Posted as of May 28, 2015