Recruiting

Observational Study

Sponsor:

University of Ottawa

Code:

NCT03993496

Conditions

Abdominal Aortic Aneurysm

Endovascular Abdominal Aortic Aneurysm Repair

Ultrasound

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Abdominal Aortic Aneurysm Sac Pulsatility

Study Details

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.

Conditions

Abdominal Aortic Aneurysm

Endovascular Abdominal Aortic Aneurysm Repair

Ultrasound

Study ID

NCT03993496

Start date

Aug 9, 2019

Status verified date

Aug, 2019

Completion date

Dec 9, 2020

Anticipated

Primary completion date

Dec 9, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

EVAR Patients

Patients with infrarenal abdominal aortic aneurysm scheduled for elective endovascular aneurysm repair (EVAR) surgery will undergo intraoperative assessments of aneurysm wall pulsatility using ultrasound M-Mode.

Interventions

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

Primary outcome measure

  • Fractional aneurysm sac size reduction 1 year after surgery [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Mark Rockley, MD

1-613-798-5555mrockley@toh.ca

Locations

The Ottawa Hospital - Civic Campus

Recruiting

Ottawa, Ontario, Canada, K1Y 4E9

Contacts

Mark Rockley, MD

1-613-798-5555mrockley@toh.ca

More Information

Sponsor

University of Ottawa

Last update posted

Aug 28, 2019

Last verified

Aug, 2019

Keywords

  • Abdominal Aortic Aneurysm
  • Endovascular Abdominal Aortic Aneurysm Repair
  • Ultrasound
  • M-mode
  • EVAR

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Ottawa on 2019-08-28.