EndoleaksAAA CEUSNCT01005212
Evaluation of Contrast-Enhanced Ultrasound to Detect Endoleaks After Endovascular Aortic Aneurysm Repair
An observational study of Endoleaks, run by E. Peden, MD at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endoleaks
- What is being tested?
- Definity
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2008to Sep 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects that have undgone endovascular repair of abdominal aortic aneurysms (EVAR).
Who may be able to join
- Age 18 years of age or greater;
- Diagnosed with abdominal aortic aneurysm and has undergone or is scheduled to undergo endovascular repair procedure.
- Has not completed the first scheduled post-treatment follow-up exam
- Voluntary participation and signature of IRB-approved informed consent.
Who cannot join
- Inability to consent (includes non-English speaking patients)
- Has already completed the first scheduled post-treatment follow-up exam.
- Clinical instability;
- Pregnancy / breast feeding;
- Known allergy to perflutren;
- Known or suspected right-to-left, bi-directional, or transient right-to-left cardiac shunts (based on manufacturer recommendations for use);
Show all 12Show fewer
- Recent heart attack (<6 months), unstable angina or uncontrolled cardiopulmonary disease
- Clinically unstable or recent worsening congestive heart failure (based on FDA warning)
- Serious ventricular arrhythmias or at high risk for arrhythmias
- Respiratory failure (based on FDA warning)
- Severe emphysema, pulmonary emboli or other conditions that compromise pulmonary arterial vasculature (based on FDA warning)
- Any reason judged by the investigators to hamper inclusion.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Houston Methodist Hospital; Department of Cardiovascualr Surgery
Houston, Texas, 77030
Houston Methodist Hospital; Department of Cardiovascular Surgery
Houston, Texas, 77030
About this study
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.
- Conditions
- Endoleaks
- Being tested
- Definity
- Keywords
- EVAR, Ultrasounds, AAA, endoleaks after endovascular repair of AAA
- Medical subject headings
- Endoleak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DefinityDrug
An intravenous line will be placed and 1.3 mL of the ultrasound contrast agent DEFINITY® will be added to 50 mL sterile saline. Flow will be initiated at 4.0 mL/minute and adjusted for optimal imaging. A maximum of 1.3 mL or one vial of ultrasound contrast will be used per patient per session according to the manufacturer's guidelines.
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoleak Detection
Persistent of a pulsatile intrasac color flow outside the stent-graft
Measured: Same day outcome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2009 (estimated)
- Study startJan 2008
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for EndoleaksStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- E. Peden, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Lantheus Medical Imaging, The Methodist Hospital Research Institute
- Responsible party
- Sponsor-investigator, E. Peden, MD, The Methodist Hospital Research Institute
- Investigators
- Eric Peden, MD, Principal investigator, Houston Methodist Hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01005212
- Sponsor's protocol ID
- Pro00001211
- Other IDs
- 1007-0202
- Acronym
- AAA CEUS
- Status last verified
- Oct 2023
- First submitted
- 28 Oct 2009
- Last updated
- 12 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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. doi: 10.1067/mva.2001.111807.
PubMed 11137921Baum 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. doi: 10.1016/s1089-2516(01)90012-5.
PubMed 11894049Bargellini 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. doi: 10.1016/j.jvs.2004.10.037.
PubMed 15696037Bendick 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. doi: 10.1067/mva.2003.17.
PubMed 12563210Bromley 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. doi: 10.1053/tvir.2001.23090.
PubMed 11981786Carrafiello G, Recaldini C, Lagana 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. doi: 10.1007/s00261-007-9268-3.
PubMed 17619925Chuter 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. doi: 10.1067/mva.2001.111487.
PubMed 11436081Dill-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. doi: 10.2214/AJR.05.0532.
PubMed 17312033Deaton DH, Makaroun MS, Fairman RM. Endoleak: predictive value for aneurysm growth at 3 years. Ann Vasc Surg. 2002 Jan;16(1):37-42. doi: 10.1007/s10016-001-0129-1. Epub 2002 Jan 16.
PubMed 11904802Eskandari 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. doi: 10.1177/096721090100900510. No abstract available.
PubMed 11489651Giannoni 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. doi: 10.1177/152660280301000208.
PubMed 12877601Giannoni 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. doi: 10.1510/icvts.2006.137265. Epub 2007 Jan 8.
PubMed 17669866Henao 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. doi: 10.1016/j.jvs.2005.09.045.
PubMed 16476596Heilberger 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. doi: 10.1177/152660289700400305.
PubMed 9291051Hiatt MD, Rubin GD. Surveillance for endoleaks: how to detect all of them. Semin Vasc Surg. 2004 Dec;17(4):268-78. doi: 10.1053/j.semvascsurg.2004.09.003.
PubMed 15614750
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Contrast-Enhanced Ultrasound to Detect Endoleaks After Endovascular Aortic Aneurysm Repair
- ClinicalTrials.gov ID
- NCT01005212
- Acronym / sponsor ID
- AAA CEUS / Pro00001211
- Conditions
- Endoleaks
- Keywords
- EVAR, Ultrasounds, AAA, endoleaks after endovascular repair of AAA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- E. Peden, MDUniversity, hospital or other
- Collaborators
- Lantheus Medical Imaging, The Methodist Hospital Research Institute
- Study start
- Jan 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 30 Oct 2009 (estimated)
- Results
- Posted 12 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects that have undgone endovascular repair of abdominal aortic aneurysms (EVAR).
Key inclusion criteria (4 listed)
- Age 18 years of age or greater;
- Diagnosed with abdominal aortic aneurysm and has undergone or is scheduled to undergo endovascular repair procedure.
- Has not completed the first scheduled post-treatment follow-up exam
- Voluntary participation and signature of IRB-approved informed consent.
Key exclusion criteria (12 listed)
- Inability to consent (includes non-English speaking patients)
- Has already completed the first scheduled post-treatment follow-up exam.
- Clinical instability;
- Pregnancy / breast feeding;
- Known allergy to perflutren;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DefinityAn intravenous line will be placed and 1.3 mL of the ultrasound contrast agent DEFINITY® will be added to 50 mL sterile saline. Flow will be initiated at 4.0 mL/minute and adjusted for optimal imaging. A maximum of 1.3 mL or one vial of ultrasound contrast will be used per patient per session according to the manufacturer's guidelines. | Drug | – |
Primary outcome
Endoleak Detection
Time frame: Same day outcome
Persistent of a pulsatile intrasac color flow outside the stent-graft
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11137921Baum 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. doi: 10.1067/mva.2001.111807.
- Background: PubMed 11894049Baum 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. doi: 10.1016/s1089-2516(01)90012-5.
- Background: PubMed 15696037Bargellini 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. doi: 10.1016/j.jvs.2004.10.037.
- Background: PubMed 12563210Bendick 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. doi: 10.1067/mva.2003.17.
- Background: PubMed 11981786Bromley 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. doi: 10.1053/tvir.2001.23090.
- Background: PubMed 17619925Carrafiello G, Recaldini C, Lagana 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. doi: 10.1007/s00261-007-9268-3.
- Background: PubMed 11436081Chuter 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. doi: 10.1067/mva.2001.111487.
- Background: PubMed 17312033Dill-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. doi: 10.2214/AJR.05.0532.
- Background: PubMed 11904802Deaton DH, Makaroun MS, Fairman RM. Endoleak: predictive value for aneurysm growth at 3 years. Ann Vasc Surg. 2002 Jan;16(1):37-42. doi: 10.1007/s10016-001-0129-1. Epub 2002 Jan 16.
- Background: PubMed 11489651Eskandari 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. doi: 10.1177/096721090100900510. No abstract available.
- Background: PubMed 12877601Giannoni 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. doi: 10.1177/152660280301000208.
- Background: PubMed 17669866Giannoni 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. doi: 10.1510/icvts.2006.137265. Epub 2007 Jan 8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Peden, MD principal investigator
Houston Methodist Hosptial
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endoleaks, run by E. Peden, MD at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endoleak Detection (time frame: Same day outcome). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01005212, which also lists 29 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.