Abdominal Aortic Aneurysm Clinical Trial
Official title:
Intraoperative Assessment of Pulsatile Aneurysm Wall Motion During Endovascular Aneurysm Repair
Endovascular abdominal aortic aneurysm repair (EVAR) aims to reduce the risk of aneurysm (AAA) rupture by reducing the blood pressure transmitted to the wall of the aneurysm. Aneurysms that remain pressurized despite EVAR may continue to grow, therefore requiring additional surgical interventions. The purpose of this study is to infer the reduction of pressure transmitted to the aneurysm wall by using intraoperative ultrasound ('M-Mode') to assess the pulsatility of the aneurysm wall. The hypothesis is that intraoperative reduction in aneurysm wall pulsatility after EVAR will correlate with improved aneurysm sac size reduction.
Endovascular abdominal aortic aneurysm repair (EVAR) aims to reduce the risk of aneurysm
(AAA) rupture by reducing the blood pressure transmitted to the wall of the aneurysm.
Unfortunately, this procedure is not always successful, and patients need to return to the
operating room for further procedures because the aneurysm wall remains pressurized and the
aneurysm continues to grow. Currently, there is no standard non-invasive way of measuring
aneurysm pressure. The purpose of this study is to infer the reduction of pressure
transmitted to the aneurysm wall by using intraoperative ultrasound ('M-Mode') to assess the
pulsatility of the aneurysm wall. The hypothesis is that intraoperative reduction in aneurysm
wall pulsatility after EVAR will correlate with improved aneurysm sac size reduction. This is
clinically relevant because physiologic intraoperative feedback of aneurysm pressure may
potentially influence surgical decision making in the future, reducing unnecessary
re-interventions. This will also improve our understanding of the intraoperative physiologic
response to EVAR.
Our primary research question is in patients receiving elective endovascular repair of
abdominal aortic aneurysms (EVAR), does the change in intraoperative ultrasound estimated
aneurysm wall pressure during EVAR correlate with aneurysm sac size reduction 1 year after
surgery? Secondary objectives are to assess correlation between intraoperative ultrasound
estimated aneurysm wall pressure and endovascular leaks and aneurysm-related
re-interventions.
A prospective, observational, assessor-blinded and surgeon-blinded study will be conducted at
the TOH Civic Campus in Ottawa, ON in order to satisfy the objectives of the study.
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