Clinical Trial: Contrast Enhanced Ultrasound vs. Computed Tomographic Angiography in the Detection of Endoleaks Following AAA Repair

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Comparison of Contrast Enhanced Ultrasound and the Gold Standard Computed Tomographic Angiography in Detection of Endoleak Following Endovascular Abdominal Aortic Aneurysm

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 Summary:

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.

Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Michigan

Dates:
Date Received: October 28, 2010
Date Started: December 2010
Date Completion:
Last Updated: December 9, 2015
Last Verified: December 2015