CQDSA in Evaluation of Prognosis After EVAR

Aortic Aneurysm, Abdominal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02016131
• Other study ID #: CQDSA_EVAR
• Status: Completed
• Phase: N/A
• First received: December 14, 2013
• Last updated: May 26, 2015
• Start date: January 2012
• Est. completion date: March 2015

Study information

• Verified date: May 2015
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: March 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Endoleak

Locations

Country	Name	City	State
China	Zhongshan Hospital	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital	Siemens Ltd., China, Shanghai, China.

Country where clinical trial is conducted

China, 

References & Publications (18)

Benndorf G. Color-coded digital subtraction angiography: the end of a monochromatic era? AJNR Am J Neuroradiol. 2010 May;31(5):925-7. doi: 10.3174/ajnr.A2077. Epub 2010 Apr 15. — View Citation

Brady AR, Thompson SG, Fowkes FG, Greenhalgh RM, Powell JT; UK Small Aneurysm Trial Participants. Abdominal aortic aneurysm expansion: risk factors and time intervals for surveillance. Circulation. 2004 Jul 6;110(1):16-21. Epub 2004 Jun 21. — View Citation

Hinnen JW, Koning OH, van Bockel JH, Hamming JF. Aneurysm sac pressure after EVAR: the role of endoleak. Eur J Vasc Endovasc Surg. 2007 Oct;34(4):432-41; discussion 442-3. Epub 2007 Aug 1. Review. — View Citation

Hunter GJ, Hunter JV, Brown NJ. Parametric imaging using digital subtraction angiography. Br J Radiol. 1986 Jan;59(697):7-11. — View Citation

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Lederle FA, Johnson GR, Wilson SE, Chute EP, Littooy FN, Bandyk D, Krupski WC, Barone GW, Acher CW, Ballard DJ. Prevalence and associations of abdominal aortic aneurysm detected through screening. Aneurysm Detection and Management (ADAM) Veterans Affairs Cooperative Study Group. Ann Intern Med. 1997 Mar 15;126(6):441-9. — View Citation

Lederle FA, Wilson SE, Johnson GR, Reinke DB, Littooy FN, Acher CW, Ballard DJ, Messina LM, Gordon IL, Chute EP, Krupski WC, Busuttil SJ, Barone GW, Sparks S, Graham LM, Rapp JH, Makaroun MS, Moneta GL, Cambria RA, Makhoul RG, Eton D, Ansel HJ, Freischlag JA, Bandyk D; Aneurysm Detection and Management Veterans Affairs Cooperative Study Group. Immediate repair compared with surveillance of small abdominal aortic aneurysms. N Engl J Med. 2002 May 9;346(19):1437-44. — View Citation

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Moll FL, Powell JT, Fraedrich G, Verzini F, Haulon S, Waltham M, van Herwaarden JA, Holt PJ, van Keulen JW, Rantner B, Schlösser FJ, Setacci F, Ricco JB; European Society for Vascular Surgery. Management of abdominal aortic aneurysms clinical practice guidelines of the European society for vascular surgery. Eur J Vasc Endovasc Surg. 2011 Jan;41 Suppl 1:S1-S58. doi: 10.1016/j.ejvs.2010.09.011. Review. — View Citation

Mortality results for randomised controlled trial of early elective surgery or ultrasonographic surveillance for small abdominal aortic aneurysms. The UK Small Aneurysm Trial Participants. Lancet. 1998 Nov 21;352(9141):1649-55. — View Citation

Reed WW, Hallett JW Jr, Damiano MA, Ballard DJ. Learning from the last ultrasound. A population-based study of patients with abdominal aortic aneurysm. Arch Intern Med. 1997 Oct 13;157(18):2064-8. — View Citation

Scott RA, Ashton HA, Lamparelli MJ, Harris GJ, Stevens JW. A 14-year experience with 6 cm as a criterion for surgical treatment of abdominal aortic aneurysm. Br J Surg. 1999 Oct;86(10):1317-21. — View Citation

Scott RA, Wilson NM, Ashton HA, Kay DN. Is surgery necessary for abdominal aortic aneurysm less than 6 cm in diameter? Lancet. 1993 Dec 4;342(8884):1395-6. — View Citation

Strother CM, Bender F, Deuerling-Zheng Y, Royalty K, Pulfer KA, Baumgart J, Zellerhoff M, Aagaard-Kienitz B, Niemann DB, Lindstrom ML. Parametric color coding of digital subtraction angiography. AJNR Am J Neuroradiol. 2010 May;31(5):919-24. doi: 10.3174/ajnr.A2020. Epub 2010 Feb 18. — View Citation

Tenjin H, Asakura F, Nakahara Y, Matsumoto K, Matsuo T, Urano F, Ueda S. Evaluation of intraaneurysmal blood velocity by time-density curve analysis and digital subtraction angiography. AJNR Am J Neuroradiol. 1998 Aug;19(7):1303-7. — View Citation

Thompson AR, Cooper JA, Ashton HA, Hafez H. Growth rates of small abdominal aortic aneurysms correlate with clinical events. Br J Surg. 2010 Jan;97(1):37-44. doi: 10.1002/bjs.6779. — View Citation

Veith FJ, Baum RA, Ohki T, Amor M, Adiseshiah M, Blankensteijn JD, Buth J, Chuter TA, Fairman RM, Gilling-Smith G, Harris PL, Hodgson KJ, Hopkinson BR, Ivancev K, Katzen BT, Lawrence-Brown M, Meier GH, Malina M, Makaroun MS, Parodi JC, Richter GM, Rubin GD, Stelter WJ, White GH, White RA, Wisselink W, Zarins CK. Nature and significance of endoleaks and endotension: summary of opinions expressed at an international conference. J Vasc Surg. 2002 May;35(5):1029-35. Review. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	15 seconds	No
Primary	ROI Peak/Ref Peak	It is the ratio of intensity peak between the endoleak and the reference in the aorta.	15 seconds	No
Primary	ROI TTP (Time to peak)	Peak time of ROI in the vicinity of endoleak entry	15 seconds	No
Primary	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.	15 seconds	No