Endovascular Abdominal Aortic Aneurysm RepairNCT01022892
Contrast Ultrasound in the Surveillance of Endovascular Abdominal Aortic Aneurysm Repair
An observational study of Endovascular Abdominal Aortic Aneurysm Repair, run by Ottawa Hospital Research Institute.
Trial summary
The purpose of this study is to support the suspected expectation that Contrast enhanced Ultrasound (CUS) detects all endoleaks that have been detected by Computed Tomography (CT), and also find a number of leaks missed by CT. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Endovascular Abdominal Aortic Aneurysm Repair
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Mar 2012
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All patients who underwent EVAR at The Ottawa Hospital and are currently undergoing post-EVAR surveillance will be eligible for the study.
Who may be able to join
- All patients who underwent EVAR at The Ottawa Hospital and currently under post-EVAR surveillance at The Ottawa Hospital.
Who cannot join
- Unable to consent for injection of contrast
- Unable to acquire IV access
- Right-to-left, bi-directional, or transient right-to-left cardiac shunts
- Severe pulmonary disease
- Previous hypersensitivity to DEFINITY® or its components
- Unable to be followed as a outpatient by the Vascular Diagnostic Center
About this study
The purpose of this study is to support the suspected expectation that Contrast enhanced Ultrasound (CUS) detects all endoleaks that have been detected by Computed Tomography (CT), and also find a number of leaks missed by CT.
The investigators' primary goal is to detect no difference between CT and CUS and provide evidence that CUS is a possible alternative to CT.
- Keywords
- Endovascular, Abdominal, Aortic, Aneurysm, Repair, Surveillance, EVAR, CT, Scan, Endoleaks, Contrast, Enhanced, Ultrasound, Definity, AAA, imaging, No Endoleaks
- Medical subject headings
- Aneurysm, Endoleak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 - Pilot phase | Total of 10 patients currently undergoing EVAR Surveillance. These 10 patients include 5 patients with endoleak known from a recent CT scan and 5 patients with no endoleak and shrinking aneurysm. | |
| Phase 2 - Blinded from CT Scan | This phase of study involves recruitment of 150 patients currently under post-EVAR surveillance. The physicians and ultrasound technologists will be blinded to the result of the CT Scan when performing and interpreting the CUS. The current schedule for EVAR Surveillance will be maintained so that an individual may receive more than one enhanced CT Scan and CUS during the 18 months of the study. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2009 (estimated)
- Study startSep 2009
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endovascular Abdominal Aortic Aneurysm RepairStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Sudhir Nagpal, Ottawa Hospital Research Institute
- Investigators
- Sudhir Nagpal, MD, Principal investigator, The Ottawa Hospital - Division of Vascular & Endovascular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01022892
- Sponsor's protocol ID
- 2007607-01H
- Status last verified
- Mar 2012
- First submitted
- 26 Nov 2009
- Last updated
- 7 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast Ultrasound in the Surveillance of Endovascular Abdominal Aortic Aneurysm Repair
- ClinicalTrials.gov ID
- NCT01022892
- Acronym / sponsor ID
- 2007607-01H
- Keywords
- Endovascular, Abdominal, Aortic, Aneurysm, Repair, Surveillance, EVAR, CT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 1 Dec 2009 (estimated)
- 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.
The purpose of this study is to support the suspected expectation that Contrast enhanced Ultrasound (CUS) detects all endoleaks that have been detected by Computed Tomography (CT), and also find a number of leaks missed by CT.
The investigators' primary goal is to detect no difference between CT and CUS and provide evidence that CUS is a possible alternative to CT.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1 - Pilot phase | – | –Total of 10 patients currently undergoing EVAR Surveillance. These 10 patients include 5 patients with endoleak known from a recent CT scan and 5 patients with no endoleak and shrinking aneurysm. |
| Phase 2 - Blinded from CT Scan | – | –This phase of study involves recruitment of 150 patients currently under post-EVAR surveillance. The physicians and ultrasound technologists will be blinded to the result of the CT Scan when performing and interpreting the CUS. The current schedule for EVAR Surveillance will be maintained so that an individual may receive more than one enhanced CT Scan and CUS during the 18 months of the study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who underwent EVAR at The Ottawa Hospital and are currently undergoing post-EVAR surveillance will be eligible for the study.
Key inclusion criteria (1 listed)
- All patients who underwent EVAR at The Ottawa Hospital and currently under post-EVAR surveillance at The Ottawa Hospital.
Key exclusion criteria (6 listed)
- Unable to consent for injection of contrast
- Unable to acquire IV access
- Right-to-left, bi-directional, or transient right-to-left cardiac shunts
- Severe pulmonary disease
- Previous hypersensitivity to DEFINITY® or its components
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2012.
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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.
Sudhir Nagpal, MD principal investigator
The Ottawa Hospital - Division of Vascular & Endovascular Surgery
Questions about this trial
What is this clinical trial studying?
An observational study of Endovascular Abdominal Aortic Aneurysm Repair, run by Ottawa Hospital Research Institute.
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 1 inclusion and 6 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: finished, as of the sponsor's last update on 7 Mar 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 7 Mar 2012.