Ignite Creation Date:
2024-05-06 @ 1:19 PM
Last Modification Date:
2024-10-26 @ 1:12 PM
Study NCT ID:
NCT03993496
Status:
UNKNOWN
Last Update Posted:
2019-08-28
First Post:
2019-06-18
Brief Title:
Intraoperative Assessment of Pulsatile Aneurysm Wall Motion During Endovascular Aneurysm Repair
Sponsor:
University of Ottawa
Organization:
University of Ottawa
Study Overview
Official Title:
Intraoperative Assessment of Pulsatile Aneurysm Wall Motion During Endovascular Aneurysm Repair
Status:
UNKNOWN
Status Verified Date:
2019-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None