Ignite Creation Date:
2024-05-06 @ 2:18 AM
Last Modification Date:
2024-10-26 @ 11:16 AM
Study NCT ID:
NCT02016131
Status:
COMPLETED
Last Update Posted:
2015-05-28
First Post:
2013-12-14
Brief Title:
CQDSA in Evaluation of Prognosis After EVAR
Sponsor:
Shanghai Zhongshan Hospital
Organization:
Shanghai Zhongshan Hospital
Study Overview
Official Title:
Application of Color-coded Quantitative Digital Subtraction Angiography in Evaluation of Prognosis After Endovascular Repairment of Abdominal Aortic Aneurysm
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 PeakRef 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 AUCRef 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
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 PeakRef 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 AUCRef 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None