Abdominal Aortic Aneurysm (AAA)Phase 1NCT02295137
Image Fusion of Preprocedural CTA With Real Time Fluoroscopy to Enhance EVAR Repair
A Phase 1 study testing Using pre-procedural CTA to guide advanced EVAR procedure in people with Abdominal Aortic Aneurysm (AAA), run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Abdominal Aortic Aneurysm (AAA) is a potentially life threatening condition. If the aneurysm ruptures, the mortality can be as high as 80%. Endovascular aneurysms repair (EVAR) is a minimal invasive procedure and has been widely used on treating AAA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm (AAA)
- What is being tested?
- Using pre-procedural CTA to guide advanced EVAR procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2014to Oct 2015
- Phase
- Phase 1
- 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
Who may be able to join
- male or female >= 18 years;
- scheduled for advanced EVAR for abdominal aortic aneurysm.
Who cannot join
- Pregnancy;
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Toronto General Hospital
Toronto, Ontario, M5G 1C4
Kong Teng Tan, MD, 416-340-4800 ext. 6166, kongteng.tan@uhn.ca
About this study
Official title: Image Fusion of Pre-procedural CTA With Real-time Fluoroscopy to Guide Proper Renal and Visceral Arteries Catheterization During Advanced Endovascular Aortic Aneurysms Repair: A Feasibility Study
Abdominal Aortic Aneurysm (AAA) is a potentially life threatening condition. If the aneurysm ruptures, the mortality can be as high as 80%. Endovascular aneurysms repair (EVAR) is a minimal invasive procedure and has been widely used on treating AAA. Advanced endovascular techniques are used to treat patients with more complex pathology by using custom-made devices and additional stents. In order to accomplish the technical success on advanced EVAR, with the current imaging equipment and technique for EVAR procedures (i.e. live x-ray fluoroscopy and 2-D digital subtraction angiography (DSA)), multiple angiograms on the target arteries (arteriograms) are required. Subsequently patients are exposed to higher dose of contrast and radiation, compared to conventional EVAR. This study is to assess the feasibility of proper visceral and renal arteries catheterization using a 3D model obtained from pre-procedural computed tomographic angiography (CTA), fused with real-time fluoroscopy, without contrast injection or angiographic run-offs thus minimizing the contrast use and patient radiation exposure while achieving procedure success during Advanced EVAR.
- Conditions
- Abdominal Aortic Aneurysm (AAA)
- Being tested
- Using pre-procedural CTA to guide advanced EVAR procedure
- 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.
Using pre-procedural CTA to guide advanced EVAR procedureProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| pre-procedure image guidance | Experimental | Not described Receives: Procedure: Using pre-procedural CTA to guide advanced EVAR procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure success
Evaluate the technical success of advanced EVAR by using pre-procedural CTA images as guidance
Measured: within 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startFeb 2014
- Primary completionOct 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic Aneurysm (AAA)Studies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kong Teng Tan, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02295137
- Sponsor's protocol ID
- UHN
- Status last verified
- Oct 2014
- First submitted
- 27 Oct 2014
- Last updated
- 20 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Image Fusion of Pre-procedural CTA With Real-time Fluoroscopy to Guide Proper Renal and Visceral Arteries Catheterization During Advanced Endovascular Aortic Aneurysms Repair: A Feasibility Study
- ClinicalTrials.gov ID
- NCT02295137
- Acronym / sponsor ID
- UHN
- Conditions
- Abdominal Aortic Aneurysm (AAA)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 20 Nov 2014 (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.
Abdominal Aortic Aneurysm (AAA) is a potentially life threatening condition. If the aneurysm ruptures, the mortality can be as high as 80%. Endovascular aneurysms repair (EVAR) is a minimal invasive procedure and has been widely used on treating AAA. Advanced endovascular techniques are used to treat patients with more complex pathology by using custom-made devices and additional stents. In order to accomplish the technical success on advanced EVAR, with the current imaging equipment and technique for EVAR procedures (i.e. live x-ray fluoroscopy and 2-D digital subtraction angiography (DSA)), multiple angiograms on the target arteries (arteriograms) are required. Subsequently patients are exposed to higher dose of contrast and radiation, compared to conventional EVAR. This study is to assess the feasibility of proper visceral and renal arteries catheterization using a 3D model obtained from pre-procedural computed tomographic angiography (CTA), fused with real-time fluoroscopy, without contrast injection or angiographic run-offs thus minimizing the contrast use and patient radiation exposure while achieving procedure success during Advanced EVAR.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pre-procedure image guidance | Experimental | Procedure: Using pre-procedural CTA to guide advanced EVAR procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- male or female >= 18 years;
- scheduled for advanced EVAR for abdominal aortic aneurysm.
Key exclusion criteria (1 listed)
- Pregnancy;
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 |
|---|---|---|
| Using pre-procedural CTA to guide advanced EVAR procedure | Procedure or surgery | pre-procedure image guidance |
Primary outcome
Procedure success
Time frame: within 1 day
Evaluate the technical success of advanced EVAR by using pre-procedural CTA images as guidance
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2014.
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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.
Kong Teng Tan, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Using pre-procedural CTA to guide advanced EVAR procedure in people with Abdominal Aortic Aneurysm (AAA), run by University Health Network, Toronto 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 2 inclusion and 1 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 20 Nov 2014. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Kong Teng Tan, MD (416-340-4800 ext. 6166, kongteng.tan@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure success (time frame: within 1 day). 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 20 Nov 2014.