NCT03993496

Intraoperative Assessment of Pulsatile Aneurysm Wall Motion During Endovascular Aneurysm Repair

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: University of Ottawa · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Abdominal Aortic Aneurysm
• Endovascular Abdominal Aortic Aneurysm Repair
• Ultrasound

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Abdominal Aortic Aneurysm Sac Pulsatility	Measurements of aortic wall pulsatility will be performed using trans-abdominal ultrasound through the non-sterile field of the upper abdomen, while the surgeons operate through the groins. The pulsatilty of the aneurysm will then be measured using transverse views in 'M-Mode' of the ultrasound, and measures the aneurysm wall displacement during a cardiac cycle; the minimum diameter (diastole) and maximum diameter (systole) will be measured. These measurements will occur during surgery: 1. Prior to EVAR deployment 2. After EVAR deployment, but before balloon affixation to the aortic wall 3. After EVAR deployment and after affixation

Timeline

• Start date: 2019-08-09
• Primary completion: 2019-12-09
• Completion: 2020-12-09
• First posted: 2019-06-20
• Last updated: 2019-08-28

Locations

1 site across 1 country: Canada