AAA CEUS: Evaluation of Contrast-Enhanced Ultrasound to Detect Endoleaks After Endovascular Aortic Aneurysm Repair

• Sponsor: E. Peden, MD (Other)
• Overall Status: Completed
• CT.gov ID: NCT01005212
• Collaborator: Lantheus Medical Imaging (Industry), The Methodist Hospital Research Institute (Other)
• Enrollment: 40
• Locations: 2
• Duration (Months): 32
• Patients Per Site: 20
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

This study will be a cross-sectional survey of interobserver variability associated with contrast enhanced ultrasound (CEUS) to detect endoleaks using computed tomographic angiography (CTA) as the practice standard. The investigators will enroll 40 consecutive patients undergoing endovascular abdominal aortic aneurysm repair (EVAR). At the first follow-up visit after the procedure, participants will undergo two abdominal ultrasound examinations with and without contrast, and one CTA. Analyses will be conducted to examine interobserver variability in the detection and characterization of endoleaks using contrast-enhanced ultrasound (CEUS). Other endpoints include examination of sensitivity and specificity of CEUS compared to CTA, and characterization of the number and types of endoleaks detected.

Condition or Disease	Intervention/Treatment	Phase
Endoleaks	Drug: Definity

Study Design

• Study Type: Observational
• Actual Enrollment: 40 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Evaluation of Contrast-Enhanced Ultrasound to Detect Endoleaks After Endovascular Aortic Aneurysm Repair
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Sep 1, 2010
• Actual Study Completion Date: Sep 1, 2010

Outcome Measures

Primary Outcome Measures

1. To examine the sensitivity and specificity of CEUS compared to CTA Hypothesis [30 Days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Age 18 years of age or greater;

2. Diagnosed with abdominal aortic aneurysm and has undergone or is scheduled to undergo endovascular repair procedure.

3. Has not completed the first scheduled post-treatment follow-up exam

4. Voluntary participation and signature of IRB-approved informed consent.

Exclusion Criteria:

1. Inability to consent (includes non-English speaking patients)

2. Has already completed the first scheduled post-treatment follow-up exam.

3. Clinical instability;

4. Pregnancy / breast feeding;

5. Known allergy to perflutren;

6. Known or suspected right-to-left, bi-directional, or transient right-to-left cardiac shunts (based on manufacturer recommendations for use);

7. Recent heart attack (<6 months), unstable angina or uncontrolled cardiopulmonary disease

8. Clinically unstable or recent worsening congestive heart failure (based on FDA warning)

9. Serious ventricular arrhythmias or at high risk for arrhythmias

10. Respiratory failure (based on FDA warning)

11. Severe emphysema, pulmonary emboli or other conditions that compromise pulmonary arterial vasculature (based on FDA warning)

12. Any reason judged by the investigators to hamper inclusion.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Houston Methodist Hospital; Department of Cardiovascualr Surgery	Houston	Texas	United States	77030
2	Houston Methodist Hospital; Department of Cardiovascular Surgery	Houston	Texas	United States	77030

Sponsors and Collaborators

• E. Peden, MD
• Lantheus Medical Imaging
• The Methodist Hospital Research Institute

Investigators

• Principal Investigator: Eric Peden, MD, Houston Methodist Hosptial

Study Documents (Full-Text)

None provided.

More Information

Publications

• Bargellini I, Napoli V, Petruzzi P, Cioni R, Vignali C, Sardella SG, Ferrari M, Bartolozzi C. Type II lumbar endoleaks: hemodynamic differentiation by contrast-enhanced ultrasound scanning and influence on aneurysm enlargement after endovascular aneurysm repair. J Vasc Surg. 2005 Jan;41(1):10-8.
• Baum RA, Carpenter JP, Cope C, Golden MA, Velazquez OC, Neschis DG, Mitchell ME, Barker CF, Fairman RM. Aneurysm sac pressure measurements after endovascular repair of abdominal aortic aneurysms. J Vasc Surg. 2001 Jan;33(1):32-41.
• Baum RA, Carpenter JP, Stavropoulous SW, Fairman RM. Diagnosis and management of type 2 endoleaks after endovascular aneurysm repair. Tech Vasc Interv Radiol. 2001 Dec;4(4):222-6. Review.
• Bendick PJ, Bove PG, Long GW, Zelenock GB, Brown OW, Shanley CJ. Efficacy of ultrasound scan contrast agents in the noninvasive follow-up of aortic stent grafts. J Vasc Surg. 2003 Feb;37(2):381-5.
• Bromley PJ, Kaufman JA. Abdominal aortic aneurysms before and after endograft implantation: evaluation by computed tomography. Tech Vasc Interv Radiol. 2001 Mar;4(1):15-26. Review.
• Carrafiello G, Recaldini C, Laganà D, Piffaretti G, Fugazzola C. Endoleak detection and classification after endovascular treatment of abdominal aortic aneurysm: value of CEUS over CTA. Abdom Imaging. 2008 May-Jun;33(3):357-62. Review.
• Chuter TA, Faruqi RM, Sawhney R, Reilly LM, Kerlan RB, Canto CJ, Lukaszewicz GC, Laberge JM, Wilson MW, Gordon RL, Wall SD, Rapp J, Messina LM. Endoleak after endovascular repair of abdominal aortic aneurysm. J Vasc Surg. 2001 Jul;34(1):98-105.
• Deaton DH, Makaroun MS, Fairman RM. Endoleak: predictive value for aneurysm growth at 3 years. Ann Vasc Surg. 2002 Jan;16(1):37-42. Epub 2002 Jan 16.
• Dill-Macky MJ, Wilson SR, Sternbach Y, Kachura J, Lindsay T. Detecting endoleaks in aortic endografts using contrast-enhanced sonography. AJR Am J Roentgenol. 2007 Mar;188(3):W262-8.
• Eskandari MK, Yao JS, Pearce WH, Rutherford RB, Veith FJ, Harris P, Bernhard VM, Becker GJ, Morasch MD, Chrisman HB, Ryu RK, Matsumura JS. Surveillance after endoluminal repair of abdominal aortic aneurysms. Cardiovasc Surg. 2001 Oct;9(5):469-71.
• Giannoni MF, Fanelli F, Citone M, Cristina Acconcia M, Speziale F, Gossetti B. Contrast ultrasound imaging: the best method to detect type II endoleak during endovascular aneurysm repair follow-up. Interact Cardiovasc Thorac Surg. 2007 Jun;6(3):359-62. Epub 2007 Jan 8.
• Giannoni MF, Palombo G, Sbarigia E, Speziale F, Zaccaria A, Fiorani P. Contrast-enhanced ultrasound imaging for aortic stent-graft surveillance. J Endovasc Ther. 2003 Apr;10(2):208-17.
• Heilberger P, Schunn C, Ritter W, Weber S, Raithel D. Postoperative color flow duplex scanning in aortic endografting. J Endovasc Surg. 1997 Aug;4(3):262-71.
• Henao EA, Hodge MD, Felkai DD, McCollum CH, Noon GP, Lin PH, Lumsden AB, Bush RL. Contrast-enhanced Duplex surveillance after endovascular abdominal aortic aneurysm repair: improved efficacy using a continuous infusion technique. J Vasc Surg. 2006 Feb;43(2):259-64; discussion 264.
• Hiatt MD, Rubin GD. Surveillance for endoleaks: how to detect all of them. Semin Vasc Surg. 2004 Dec;17(4):268-78. Review.
• Jaakkola P, Hippeläinen M, Farin P, Rytkönen H, Kainulainen S, Partanen K. Interobserver variability in measuring the dimensions of the abdominal aorta: comparison of ultrasound and computed tomography. Eur J Vasc Endovasc Surg. 1996 Aug;12(2):230-7.
• Jones WB, Taylor SM, Kalbaugh CA, Joels CS, Blackhurst DW, Langan EM 3rd, Gray BH, Youkey JR. Lost to follow-up: a potential under-appreciated limitation of endovascular aneurysm repair. J Vasc Surg. 2007 Sep;46(3):434-40; discussion 440-1.
• McWilliams RG, Martin J, White D, Gould DA, Rowlands PC, Haycox A, Brennan J, Gilling-Smith GL, Harris PL. Detection of endoleak with enhanced ultrasound imaging: comparison with biphasic computed tomography. J Endovasc Ther. 2002 Apr;9(2):170-9.
• Muthu C, Gordon M, Buckenham T, Lewis D. The case for lifelong follow-up after endovascular aneurysm repair. N Z Med J. 2005 Nov 11;118(1225):U1729.
• Napoli V, Bargellini I, Sardella SG, Petruzzi P, Cioni R, Vignali C, Ferrari M, Bartolozzi C. Abdominal aortic aneurysm: contrast-enhanced US for missed endoleaks after endoluminal repair. Radiology. 2004 Oct;233(1):217-25.
• Resch T, Ivancev K, Brunkwall J, Nyman U, Malina M, Lindblad B. Distal migration of stent-grafts after endovascular repair of abdominal aortic aneurysms. J Vasc Interv Radiol. 1999 Mar;10(3):257-64; discussion 265-6.
• Rydberg J, Lalka S, Johnson M, Cikrit D, Dalsing M, Sawchuk A, Shafique S. Characterization of endoleaks by dynamic computed tomographic angiography. Am J Surg. 2004 Nov;188(5):538-43.
• Sawhney R, Kerlan RK, Wall SD, Chuter TA, Ruiz DE, Canto CJ, LaBerge JM, Reilly LM, Yee J, Wilson MW, Jean-Claude J, Faruqi RM, Gordon RL. Analysis of initial CT findings after endovascular repair of abdominal aortic aneurysm. Radiology. 2001 Jul;220(1):157-60.
• Singh K, Jacobsen BK, Solberg S, Bønaa KH, Kumar S, Bajic R, Arnesen E. Intra- and interobserver variability in the measurements of abdominal aortic and common iliac artery diameter with computed tomography. The Tromsø study. Eur J Vasc Endovasc Surg. 2003 May;25(5):399-407.
• Singh K, Jacobsen BK, Solberg S, Kumar S, Arnesen E. The difference between ultrasound and computed tomography (CT) measurements of aortic diameter increases with aortic diameter: analysis of axial images of abdominal aortic and common iliac artery diameter in normal and aneurysmal aortas. The Tromsø Study, 1994-1995. Eur J Vasc Endovasc Surg. 2004 Aug;28(2):158-67.
• Tillich M, Hausegger KA, Tiesenhausen K, Tauss J, Groell R, Szolar DH. Helical CT angiography of stent-grafts in abdominal aortic aneurysms: morphologic changes and complications. Radiographics. 1999 Nov-Dec;19(6):1573-83.
• Wanhainen A, Bergqvist D, Björck M. Measuring the abdominal aorta with ultrasonography and computed tomography - difference and variability. Eur J Vasc Endovasc Surg. 2002 Nov;24(5):428-34.
• White GH, May J, Petrasek P, Waugh R, Stephen M, Harris J. Endotension: an explanation for continued AAA growth after successful endoluminal repair. J Endovasc Surg. 1999 Nov;6(4):308-15.
• White GH, Yu W, May J, Chaufour X, Stephen MS. Endoleak as a complication of endoluminal grafting of abdominal aortic aneurysms: classification, incidence, diagnosis, and management. J Endovasc Surg. 1997 May;4(2):152-68. Review.

• Responsible Party: E. Peden, MD, Sponsor-Investigator/Principal Investigator, The Methodist Hospital Research Institute
• ClinicalTrials.gov Identifier: NCT01005212
• Other Study ID Numbers: Pro00001211; 1007-0202
• First Posted: Oct 30, 2009
• Last Update Posted: Oct 2, 2017
• Last Verified: Sep 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by E. Peden, MD, Sponsor-Investigator/Principal Investigator, The Methodist Hospital Research Institute: EVAR; Ultrasounds; AAA; endoleaks after endovascular repair of AAA
• Additional relevant MeSH terms: Aneurysm; Aortic Aneurysm; Endoleak

Study Results

No Results Posted as of Oct 2, 2017