Abdominal Aortic AneurysmNCT03993496
Intraoperative Assessment of Pulsatile Aneurysm Wall Motion During Endovascular Aneurysm Repair
An observational study of Abdominal Aortic Aneurysm and Endovascular Abdominal Aortic Aneurysm Repair, run by University of Ottawa at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm, Endovascular Abdominal Aortic Aneurysm Repair, Ultrasound
- What is being tested?
- Abdominal Aortic Aneurysm Sac Pulsatility
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 9 Aug 2019to 9 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Elective endovascular aneurysm repair (EVAR) surgery
- Infrarenal abdominal aortic aneurysm
- Age greater than 18 years old
Who cannot join
- Prior abdominal aortic aneurysm procedures
- Inability to visualize aneurysm on ultrasound
- Inability to provide consent
- Irregular arrhythmias
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
The Ottawa Hospital - Civic Campus
Ottawa, Ontario, K1Y 4E9
Mark Rockley, MD, 1-613-798-5555, mrockley@toh.ca
Mark C Rockley, MD
About this study
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.
Read the 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.
- Being tested
- Abdominal Aortic Aneurysm Sac Pulsatility
- Keywords
- Abdominal Aortic Aneurysm, Endovascular Abdominal Aortic Aneurysm Repair, Ultrasound, M-mode, EVAR
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal Aortic Aneurysm Sac PulsatilityDiagnostic test
Also called M-Mode Ultrasound
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:
- Prior to EVAR deployment
- After EVAR deployment, but before balloon affixation to the aortic wall
- After EVAR deployment and after affixation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Abdominal Aortic Aneurysm Sac Pulsatility |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 year
Secondary outcomes (3)
Fractional aneurysm sac size reduction 30 days after surgery
Aneurysm sac size reduction will be measured using CTA 30 days after surgery. Post-operative imaging reports will be accessed through the hospital electronic health records system (EPIC).
Measured: 30 days
Endovascular leaks (Type 1, 2, 3, 4)
The presence of endovascular leaks (type 1, 2, 3, 4) will be assessed intraoperatively with a completion angiogram and CTA at 30 days postoperative. Postoperative imaging reports will be accessed through the hospital electronic heath records system (EPIC).
Measured: 30 days
Aneurysm-related re-interventions
Any aneurysm-related complications requiring re-interventions will be noted. If an additional intervention is performed in the same operation, additional measurements of aortic wall pulsatility following intervention will be included. Other post-operative re-interventions will be reviewed through EPIC.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start9 Aug 2019
- Primary completion9 Dec 2019 (estimated)
- Study completion9 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ottawa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Rockley, University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03993496
- Sponsor's protocol ID
- 20190366-01H
- Status last verified
- Aug 2019
- First submitted
- 18 Jun 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Assessment of Pulsatile Aneurysm Wall Motion During Endovascular Aneurysm Repair
- ClinicalTrials.gov ID
- NCT03993496
- Acronym / sponsor ID
- 20190366-01H
- Keywords
- Abdominal Aortic Aneurysm, Endovascular Abdominal Aortic Aneurysm Repair, Ultrasound, M-mode, EVAR
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of OttawaUniversity, hospital or other
- Study start
- 9 Aug 2019 (actual)
- Primary completion
- 9 Dec 2019 (estimated)
- Study completion
- 9 Dec 2020 (estimated)
- First posted
- 20 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EVAR Patients | – | Diagnostic Test: Abdominal Aortic Aneurysm Sac PulsatilityPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Elective endovascular aneurysm repair (EVAR) surgery
- Infrarenal abdominal aortic aneurysm
- Age greater than 18 years old
Key exclusion criteria (4 listed)
- Prior abdominal aortic aneurysm procedures
- Inability to visualize aneurysm on ultrasound
- Inability to provide consent
- Irregular arrhythmias
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal Aortic Aneurysm Sac PulsatilityAlso: M-Mode UltrasoundMeasurements 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 | Diagnostic test | EVAR Patients |
Primary outcome
Fractional aneurysm sac size reduction 1 year after surgery
Time frame: 1 year
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).
3 secondary outcomes
Fractional aneurysm sac size reduction 30 days after surgery
Time frame: 30 days
Endovascular leaks (Type 1, 2, 3, 4)
Time frame: 30 days
Aneurysm-related re-interventions
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysm and Endovascular Abdominal Aortic Aneurysm Repair, run by University of Ottawa at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark Rockley, MD (1-613-798-5555, mrockley@toh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fractional aneurysm sac size reduction 1 year after surgery (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.