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Intraoperative Assessment of Pulsatile Aneurysm Wall Motion During Endovascular Aneurysm Repair
| Condition or disease | Intervention/treatment |
|---|---|
| Abdominal Aortic Aneurysm Endovascular Abdominal Aortic Aneurysm Repair Ultrasound | Diagnostic Test: Abdominal Aortic Aneurysm Sac Pulsatility |
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 Type : | Observational |
| Estimated Enrollment : | 20 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Intraoperative Assessment of Pulsatile Aneurysm Wall Motion During Endovascular Aneurysm Repair |
| Actual Study Start Date : | August 9, 2019 |
| Estimated Primary Completion Date : | December 9, 2019 |
| Estimated Study Completion Date : | December 9, 2020 |
| Group/Cohort | Intervention/treatment |
|---|---|
|
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
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:
Other Name: M-Mode Ultrasound
|
- 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).
- Fractional aneurysm sac size reduction 30 days after surgery [ Time Frame: 30 days ]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).
- Endovascular leaks (Type 1, 2, 3, 4) [ Time Frame: 30 days ]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).
- Aneurysm-related re-interventions [ Time Frame: 1 year ]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.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
| Contact: Mark Rockley, MD | 1-613-798-5555 | mrockley@toh.ca |
| Canada, Ontario | |
| The Ottawa Hospital - Civic Campus | Recruiting |
| Ottawa, Ontario, Canada, K1Y 4E9 | |
| Contact: Mark Rockley, MD 1-613-798-5555 mrockley@toh.ca | |
| Sub-Investigator: Mark C Rockley, MD | |
| Sub-Investigator: Emily T Nham, BSc | |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date | June 18, 2019 | ||||||
| First Posted Date | June 20, 2019 | ||||||
| Last Update Posted Date | August 28, 2019 | ||||||
| Actual Study Start Date | August 9, 2019 | ||||||
| Estimated Primary Completion Date | December 9, 2019 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures |
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).
|
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| Original Primary Outcome Measures | Same as current | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures |
|
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| Original Secondary Outcome Measures | Same as current | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title | Intraoperative Assessment of Pulsatile Aneurysm Wall Motion During Endovascular Aneurysm Repair | ||||||
| Official Title | Intraoperative Assessment of Pulsatile Aneurysm Wall Motion During Endovascular Aneurysm Repair | ||||||
| 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. | ||||||
| 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. |
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| Study Type | Observational | ||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||||
| Target Follow-Up Duration | Not Provided | ||||||
| Biospecimen | Not Provided | ||||||
| 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. | ||||||
| Condition |
|
||||||
| Intervention | 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:
Other Name: M-Mode Ultrasound
|
||||||
| Study Groups/Cohorts | 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.
Intervention: Diagnostic Test: Abdominal Aortic Aneurysm Sac Pulsatility
|
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| Publications * | Not Provided | ||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status | Recruiting | ||||||
| Estimated Enrollment |
20 | ||||||
| Original Estimated Enrollment | Same as current | ||||||
| Estimated Study Completion Date | December 9, 2020 | ||||||
| Estimated Primary Completion Date | December 9, 2019 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers | No | ||||||
| Contacts |
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| Listed Location Countries | Canada | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number | NCT03993496 | ||||||
| Other Study ID Numbers | 20190366-01H | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Mark Rockley, University of Ottawa | ||||||
| Study Sponsor | University of Ottawa | ||||||
| Collaborators | Not Provided | ||||||
| Investigators | Not Provided | ||||||
| PRS Account | University of Ottawa | ||||||
| Verification Date | August 2019 | ||||||
