Clinical trial NCT03993496: Intraoperative Assessment of Pulsatile Aneurysm Wall Motion During Endovascular Aneurysm Repair
Official title: Intraoperative Assessment of Pulsatile Aneurysm Wall Motion During Endovascular Aneurysm Repair
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Abdominal Aortic Aneurysm
Endovascular Abdominal Aortic Aneurysm Repair
Ultrasound
Keywords: Abdominal Aortic Aneurysm
Endovascular Abdominal Aortic Aneurysm Repair
Ultrasound
M-mode
EVAR
Lead sponsor: University of Ottawa
Sponsor class: OTHER
First posted: 2019-06-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of anyone over the age of 18 years old with an abdominal aortic aneurysm scheduled for elective endovascular abdominal aortic aneurysm repair (EVAR) through the Division of Vascular \& Endovascular Surgery at The Ottawa Hospital, Civic Campus.

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.

Eligibility criteria: Inclusion Criteria:

* Elective endovascular aneurysm repair (EVAR) surgery
* Infrarenal abdominal aortic aneurysm
* Age greater than 18 years old

Exclusion Criteria:

* Prior abdominal aortic aneurysm procedures
* Inability to visualize aneurysm on ultrasound
* Inability to provide consent
* Irregular arrhythmias

Primary outcomes:
measure: Fractional aneurysm sac size reduction 1 year after surgery
timeFrame: 1 year
Secondary outcomes:
measure: Fractional aneurysm sac size reduction 30 days after surgery
timeFrame: 30 days
measure: Endovascular leaks (Type 1, 2, 3, 4)
timeFrame: 30 days
measure: Aneurysm-related re-interventions
timeFrame: 1 year
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital - Civic Campus
state: Ontario
Study officials:
References: