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Intraoperative Assessment of Pulsatile Aneurysm Wall Motion During Endovascular Aneurysm Repair

Abdominal Aortic Aneurysm Clinical Trial

Official title:
Intraoperative Assessment of Pulsatile Aneurysm Wall Motion During Endovascular Aneurysm Repair

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03993496
Study type Observational
Source University of Ottawa
Contact Mark Rockley, MD
Phone 1-613-798-5555
Email mrockley@toh.ca
Status Recruiting
Phase
Start date August 9, 2019
Completion date December 9, 2020
View Details
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