Thoracic Aortic AneurysmNCT06786351
Impact of Right Atrial Occlusion on TEVAR Outcomes
An observational study of Thoracic Aortic Aneurysm and Thoracic Aortic Dissection, run by University of Calgary.
Trial summary
Though the application of thoracic endovascular aortic repair (TEVAR) for treatment of aortic pathology is expanding, there remains a gap in the literature examining how intraoperative "reduction or elimination of aortic impulse" (REAI) techniques, in particular the use of right atrial occlusion, may impact patient… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Aortic Aneurysm, Thoracic Aortic Dissection, Thoracic Aorta Abnormality
- What is being tested?
- Right atrial balloon occlusion and Non right atrial balloon occlusion
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 31 Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: All patients undergoing emergency or elective thoracic endovascular aortic repair at the Peter Lougheed Centre, Calgary, Alberta
Who may be able to join
- age 18 years or older
- thoracic endovascular aortic repair
- right atrial balloon occlusion for reduction or elimination of aortic impulse
- endograft deployment in landing zones 0-3
Who cannot join
- age 18 years or younger
- non-thoracic endovascular aortic repair
- reduction or elimination of aortic impulse using technique other than right atrial balloon occlusion
- endograft deployment in landing zones 4 and beyond
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of Right Atrial Occlusion on TEVAR Outcomes: A Prospective Cohort Study
Though the application of thoracic endovascular aortic repair (TEVAR) for treatment of aortic pathology is expanding, there remains a gap in the literature examining how intraoperative "reduction or elimination of aortic impulse" (REAI) techniques, in particular the use of right atrial occlusion, may impact patient important clinical outcomes. This study aims to provide prospective data from a large cohort of TEVAR patients to explore clinical outcomes following TEVAR procedures and, specifically, whether right atrial occlusion has significant impact on clinical outcomes, as compared to other REAI techniques. The results from this study may inform future perioperative TEVAR practices and improve TEVAR patient outcomes.
- Being tested
- Right atrial balloon occlusion, Non right atrial balloon occlusion
- Keywords
- right atrial balloon occlusion, thoracic endovascular aortic repair, stent graft repair, reduction of elimination of aortic impulse
- Medical subject headings
- Aortic Aneurysm, Thoracic, Dissection, Thoracic Aorta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Right atrial balloon occlusionProcedure or surgery
Thoracic endovascular aortic repair with right atrial balloon occlusion for reduction or elimination of aortic impulse and stent graft deployment in landing zones 0-3
Non right atrial balloon occlusionProcedure or surgery
Thoracic endovascular aortic repair not using right atrial balloon occlusion for reduction or elimination of aortic impulse and stent graft deployment in landing zones 0-3
| Study group | Role | What they receive |
|---|---|---|
| Right atrial balloon occlusion | Thoracic endovascular aortic repair with right atrial balloon occlusion for reduction or elimination of aortic impulse Receives: Procedure: Right atrial balloon occlusion | |
| Non right atrial balloon occlusion | Thoracic endovascular aortic repair not using right atrial balloon occlusion for reduction or elimination of aortic impulse Receives: Procedure: Non right atrial balloon occlusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoleak occurrence up to hospital discharge
Endoleak occurrence prior to hospital discharge
Measured: end of surgery to hospital discharge up to 10 days)
Endoleak occurrence to one-year post-surgery
Endoleak occurrence within one-year of surgery
Measured: end of surgery to one-year post-surgery
Secondary outcomes (11)
Perioperative mortality to 30 days post-surgery
30-day perioperative mortality
Measured: post-surgery to 30 days post-surgery
All-cause mortality to one-year post-surgery
One-year all-cause mortality
Measured: post-surgery to one-year post-surgery
Complications: massive hemorrhage
Occurrence of massive hemorrhage
Measured: within 30 days post-surgery and at 1 year
Complications: cerebrovascular
Occurrence of cerebrovascular accident/transient ischemic attack
Measured: within 30 days post-surgery and at 1 year
Complications: spinal cord ischemia
Occurrence of spinal cord ischemia
Measured: within 30 days post-surgery and at 1 year
Complications: iliofemoral access
Occurrence of iliofemoral access complications (bleeding/infection/thrombosis)
Measured: within 30 days post-surgery and at 1 year
Complications: retrograde dissection
Occurrence of retrograde dissection
Measured: within 30 days post-surgery and at 1 year
Complications: prolonged ventilation
Occurrence of prolonged ventilation for more than 24 hours
Measured: within 30 days post-surgery and at 1 year
Complications: acute kidney injury
Occurrence of acute kidney injury
Measured: within 30 days post-surgery and at 1 year
Complications: acute kidney injury with renal replacement therapy
Occurrence of acute kidney injury requiring renal replacement therapy
Measured: within 30 days post-surgery and at 1 year
Complications: cardiovascular events
Occurrence of cardiovascular events (myocardial injury after non-cardiac surgery/cardiac arrest/myocardial infarction)
Measured: within 30 days post-surgery and at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claire Allen, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06786351
- Sponsor's protocol ID
- REB24-1367
- Status last verified
- Jun 2025
- First submitted
- 7 Jan 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Right Atrial Occlusion on TEVAR Outcomes: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06786351
- Acronym / sponsor ID
- REB24-1367
- Keywords
- right atrial balloon occlusion, thoracic endovascular aortic repair, stent graft repair, reduction of elimination of aortic impulse
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 22 Jan 2025 (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.
Though the application of thoracic endovascular aortic repair (TEVAR) for treatment of aortic pathology is expanding, there remains a gap in the literature examining how intraoperative "reduction or elimination of aortic impulse" (REAI) techniques, in particular the use of right atrial occlusion, may impact patient important clinical outcomes. This study aims to provide prospective data from a large cohort of TEVAR patients to explore clinical outcomes following TEVAR procedures and, specifically, whether right atrial occlusion has significant impact on clinical outcomes, as compared to other REAI techniques. The results from this study may inform future perioperative TEVAR practices and improve TEVAR patient outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Right atrial balloon occlusion | – | Procedure: Right atrial balloon occlusionThoracic endovascular aortic repair with right atrial balloon occlusion for reduction or elimination of aortic impulse |
| Non right atrial balloon occlusion | – | Procedure: Non right atrial balloon occlusionThoracic endovascular aortic repair not using right atrial balloon occlusion for reduction or elimination of aortic impulse |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing emergency or elective thoracic endovascular aortic repair at the Peter Lougheed Centre, Calgary, Alberta
Key inclusion criteria (4 listed)
- age 18 years or older
- thoracic endovascular aortic repair
- right atrial balloon occlusion for reduction or elimination of aortic impulse
- endograft deployment in landing zones 0-3
Key exclusion criteria (4 listed)
- age 18 years or younger
- non-thoracic endovascular aortic repair
- reduction or elimination of aortic impulse using technique other than right atrial balloon occlusion
- endograft deployment in landing zones 4 and beyond
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 |
|---|---|---|
| Right atrial balloon occlusionThoracic endovascular aortic repair with right atrial balloon occlusion for reduction or elimination of aortic impulse and stent graft deployment in landing zones 0-3 | Procedure or surgery | Right atrial balloon occlusion |
| Non right atrial balloon occlusionThoracic endovascular aortic repair not using right atrial balloon occlusion for reduction or elimination of aortic impulse and stent graft deployment in landing zones 0-3 | Procedure or surgery | Non right atrial balloon occlusion |
Primary outcome
Endoleak occurrence up to hospital discharge
Time frame: end of surgery to hospital discharge up to 10 days)
Endoleak occurrence prior to hospital discharge
Endoleak occurrence to one-year post-surgery
Time frame: end of surgery to one-year post-surgery
Endoleak occurrence within one-year of surgery
11 secondary outcomes
Perioperative mortality to 30 days post-surgery
Time frame: post-surgery to 30 days post-surgery
All-cause mortality to one-year post-surgery
Time frame: post-surgery to one-year post-surgery
Complications: massive hemorrhage
Time frame: within 30 days post-surgery and at 1 year
Complications: cerebrovascular
Time frame: within 30 days post-surgery and at 1 year
Complications: spinal cord ischemia
Time frame: within 30 days post-surgery and at 1 year
Complications: iliofemoral access
Time frame: within 30 days post-surgery and at 1 year
Complications: retrograde dissection
Time frame: within 30 days post-surgery and at 1 year
Complications: prolonged ventilation
Time frame: within 30 days post-surgery and at 1 year
Complications: acute kidney injury
Time frame: within 30 days post-surgery and at 1 year
Complications: acute kidney injury with renal replacement therapy
Time frame: within 30 days post-surgery and at 1 year
Complications: cardiovascular events
Time frame: within 30 days post-surgery and at 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Aortic Aneurysm and Thoracic Aortic Dissection, run by University of Calgary.
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 4 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: opening soon, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claire Allen, MD, FRCPC (403-, claire.allen@ahs.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endoleak occurrence up to hospital discharge (time frame: end of surgery to hospital discharge up to 10 days)). The study lists 2 primary outcomes in all. 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 29 Jun 2025.