Ignite Creation Date:
2024-05-05 @ 11:01 PM
Last Modification Date:
2024-10-26 @ 10:27 AM
Study NCT ID:
NCT01230684
Status:
TERMINATED
Last Update Posted:
2017-10-26
First Post:
2010-10-28
Brief Title:
Contrast Enhanced Ultrasound vs Computed Tomographic Angiography in the Detection of Endoleaks Following AAA Repair
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
Comparison of Contrast Enhanced Ultrasound and the Gold Standard Computed Tomographic Angiography in Detection of Endoleak Following Endovascular Abdominal Aortic Aneurysm Repair
Status:
TERMINATED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to low enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to compare two different types of imaging techniques to identify endoleaks Following the endovascular procedure subjects are seen at one month to have computed tomographic angiography CTA to confirm the graft is not leaking endoleak CTA is the standard imaging technique used to identify endoleaks This study will investigate if the image technique color duplex ultrasound with contrast enhanced ultrasound CEUS is a good tool to identify endoleaks too
Detailed Description:
Background
Abdominal aortic aneurysms AAAs continue to be a leading cause of death in older age groups In the 60-85 year-old population AAA represents the 14th-leading cause of death Federal funding through Medicare has been allocated for early detection using abdominal ultrasound screening programs Despite these more aggressive screening programs and concerted efforts by surgeons for timely repair the incidence of ruptured AAA has continued to increase
Endovascular aneurysm repair EVAR has been the most common type of repair since 2006 Multiple studies reflecting decreased perioperative morbidity and mortality over open repair make this an attractive option for patients EVAR requires more intensive follow-up than standard open surgical repair however Secondary interventions are more common to maintain seal of the endograft within the aorta and subsequent exclusion of the aneurysmal component
The term endoleak is specific to EVAR and describes the primary means by which endografts fail Type I endoleaks occur because of inadequate graft seal proximally or distally resulting in perigraft flow and aneurysm sac pressurization Type II endoleaks occur when branch arteries arising from the aneurysmal aorta back-bleed into the aneurysm sac due to collateral flow Type III endoleaks occur when flow persists between segments of a modular graft Type IV endoleaks occur when flow persists through endograft material graft porosity Type V endoleaks have also been called endotension and occur when pressurization of the sac occurs in the absence of any demonstrable endoleak Type I and Type III endoleaks are most concerning for rupture although persistent Type II endoleaks can also lead to aneurysm rupture and premature death
The most common method of EVAR follow-up is computed tomographic angiography CTA These studies allow accurate measurement of aneurysm sac diameters and volumes They also are highly sensitive and specific for endoleaks Type II endoleaks are treated if they remain persistent and are present in the setting of aneurysm sac enlargement Type I and III endoleaks are immediately treated when identified Type IV endoleaks are rarely seen with current endograft technology
Study Objectives
The purpose of the current study is to compare routine postoperative surveillance by CTA with color duplex ultrasound and contrast enhanced ultrasound CEUS for the detection of endoleaks
Study Design
This is a pilot study comparing the imaging techniques of CTA to CEUS in 25 patients undergoing EVAR at their one month post endograft surveillance The one month standard follow-up will be used for comparing techniques as this will yield the highest number of endoleak positive patients Patients will complete a color duplex examination in conjunction with CEUS using the FDA approved ultrasound contrast agent OptisonTM Perflutren Protein Type A Microspheres for Injection USP Following ultrasonographic evaluation study patients will undergo routine CTA
Eligible subjects will be asked to participate in the trial following post-op day number 1 from their endovascular procedure Study participation is 30 days 7 days
Abdominal aortic aneurysms AAAs continue to be a leading cause of death in older age groups In the 60-85 year-old population AAA represents the 14th-leading cause of death Federal funding through Medicare has been allocated for early detection using abdominal ultrasound screening programs Despite these more aggressive screening programs and concerted efforts by surgeons for timely repair the incidence of ruptured AAA has continued to increase
Endovascular aneurysm repair EVAR has been the most common type of repair since 2006 Multiple studies reflecting decreased perioperative morbidity and mortality over open repair make this an attractive option for patients EVAR requires more intensive follow-up than standard open surgical repair however Secondary interventions are more common to maintain seal of the endograft within the aorta and subsequent exclusion of the aneurysmal component
The term endoleak is specific to EVAR and describes the primary means by which endografts fail Type I endoleaks occur because of inadequate graft seal proximally or distally resulting in perigraft flow and aneurysm sac pressurization Type II endoleaks occur when branch arteries arising from the aneurysmal aorta back-bleed into the aneurysm sac due to collateral flow Type III endoleaks occur when flow persists between segments of a modular graft Type IV endoleaks occur when flow persists through endograft material graft porosity Type V endoleaks have also been called endotension and occur when pressurization of the sac occurs in the absence of any demonstrable endoleak Type I and Type III endoleaks are most concerning for rupture although persistent Type II endoleaks can also lead to aneurysm rupture and premature death
The most common method of EVAR follow-up is computed tomographic angiography CTA These studies allow accurate measurement of aneurysm sac diameters and volumes They also are highly sensitive and specific for endoleaks Type II endoleaks are treated if they remain persistent and are present in the setting of aneurysm sac enlargement Type I and III endoleaks are immediately treated when identified Type IV endoleaks are rarely seen with current endograft technology
Study Objectives
The purpose of the current study is to compare routine postoperative surveillance by CTA with color duplex ultrasound and contrast enhanced ultrasound CEUS for the detection of endoleaks
Study Design
This is a pilot study comparing the imaging techniques of CTA to CEUS in 25 patients undergoing EVAR at their one month post endograft surveillance The one month standard follow-up will be used for comparing techniques as this will yield the highest number of endoleak positive patients Patients will complete a color duplex examination in conjunction with CEUS using the FDA approved ultrasound contrast agent OptisonTM Perflutren Protein Type A Microspheres for Injection USP Following ultrasonographic evaluation study patients will undergo routine CTA
Eligible subjects will be asked to participate in the trial following post-op day number 1 from their endovascular procedure Study participation is 30 days 7 days
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Internal Grant Award | OTHER_GRANT | G009310Cardiovascular Center | None |