MedTrace Logo

Intraoperative Assessment of Pulsatile Aneurysm Wall Motion During Endovascular Aneurysm Repair

NCT03993496 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2019-08-28

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • University of Ottawa

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-09
Primary Completion
2019-12-09
Completion
2020-12-09

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03993496 on ClinicalTrials.gov