Intraoperative Assessment of Pulsatile Aneurysm Wall Motion During Endovascular Aneurysm Repair

NCT03993496 | Unknown

• 1 other identifier: 20190366-01H
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Fractional aneurysm sac size reduction 1 year after surgery

  Aneurysm sac size reduction will be measured using surveillance ultrasound 1 year after surgery. Post-operative imaging reports will be accessed through the hospital electronic health records system (EPIC).

  1 year

Secondary Outcomes (3)

• Fractional aneurysm sac size reduction 30 days after surgery

  30 days

• Endovascular leaks (Type 1, 2, 3, 4)

  30 days

• Aneurysm-related re-interventions

  1 year

Study Arms (1)

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.

Diagnostic Test: Abdominal Aortic Aneurysm Sac Pulsatility

Interventions

Abdominal Aortic Aneurysm Sac Pulsatility DIAGNOSTIC_TEST

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

Also known as: M-Mode Ultrasound

EVAR Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Ottawa: lead

Study Sites (1)

The Ottawa Hospital - Civic Campus

Ottawa, Ontario, K1Y 4E9, Canada

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Central Study Contacts

Mark Rockley, MD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Investigator

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: June 20, 2019
• Study Start: August 9, 2019
• Primary Completion: December 9, 2019
• Study Completion: December 9, 2020
• Last Updated: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)