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CQDSA in Evaluation of Prognosis After EVAR

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ClinicalTrials.gov Identifier: NCT02016131
Recruitment Status : Completed
First Posted : December 19, 2013
Last Update Posted : May 28, 2015
Sponsor:
Collaborator:
Siemens Ltd., China, Shanghai, China.
Information provided by (Responsible Party):
Zhenyu Shi, Shanghai Zhongshan Hospital

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
Endoleak Aortic Aneurysm, Abdominal

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
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 : January 2012
Actual Primary Completion Date : September 2014
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who present type I endoleak after EVAR for AAA.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02016131


Locations
China
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

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Zhenyu Shi, Associate Prof., Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT02016131     History of Changes
Other Study ID Numbers: CQDSA_EVAR
First Posted: December 19, 2013    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015

Keywords provided by Zhenyu Shi, Shanghai Zhongshan Hospital:
endoleak
EVAR
AAA
CQDSA

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Endoleak
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Postoperative Hemorrhage
Hemorrhage
Pathologic Processes
Postoperative Complications