Carbon DioxideNCT00520416
Prospective, Non-Randomized Evaluation of Carbon Dioxide Gas as a Contrast Agent in Comparison With Iodinated Contrast in Endovascular Aneurysm Repair
An observational study of Carbon Dioxide and Endovascular Abdominal Aortic Aneurym Repair, run by University of Southern California at 1 site in United States.
Trial summary
Endovascular repair of infrarenal abdominal aortic aneurysms (AAA) requires a contrast agent to identify the vascular anatomy and placement of the stent graft. Iodine contrast has traditionally been used, but has the potential to harm the kidneys. Another contrast agent is carbon dioxide gas. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Carbon Dioxide, Endovascular Abdominal Aortic Aneurym Repair, Prospective
- What is being tested?
- Carbon dioxide angiogram
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to 20 Jul 2008
- 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
Who may be able to join
- Infrarenal abdominal aortic aneurysm amendable to endovascular repair
Who cannot join
- renal failure or contraindication to receiving iodine contrast.
Trial locations and contacts
1 site in 1 country.
United States1 site
USC University Hospital
Los Angeles, California, 90033
About this study
Endovascular repair of infrarenal abdominal aortic aneurysms (AAA) requires a contrast agent to identify the vascular anatomy and placement of the stent graft. Iodine contrast has traditionally been used, but has the potential to harm the kidneys. Another contrast agent is carbon dioxide gas. It has been proven safe to use, but the quality of the images it creates needs to be compared to iodine contrast. Patients in this study undergo the endovascular AAA repair as they normally, with the iodine contrast. At the end of surgery carbon dioxide gas contrast is given as an extra step. The images will be later evaluated.
- Being tested
- Carbon dioxide angiogram
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon dioxide angiogramProcedure or surgery
see description of procedure
| Study group | Role | What they receive |
|---|---|---|
| 1 | There is no control or experimental group. The same patients undergoing endovascular AAA repair with serve as their own control Receives: Procedure: Carbon dioxide angiogram |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2007 (estimated)
- Study startOct 2006
- Study completion20 Jul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carbon DioxideStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fred A Weaver, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00520416
- Sponsor's protocol ID
- HS-06-00263
- Status last verified
- Mar 2017
- First submitted
- 22 Aug 2007
- Last updated
- 17 Mar 2017
- 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 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Non-Randomized Evaluation of Carbon Dioxide Gas as a Contrast Agent in Comparison With Iodinated Contrast in Endovascular Aneurysm Repair
- ClinicalTrials.gov ID
- NCT00520416
- Acronym / sponsor ID
- HS-06-00263
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- Oct 2006
- Study completion
- 20 Jul 2008 (actual)
- First posted
- 24 Aug 2007 (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.
Endovascular repair of infrarenal abdominal aortic aneurysms (AAA) requires a contrast agent to identify the vascular anatomy and placement of the stent graft. Iodine contrast has traditionally been used, but has the potential to harm the kidneys. Another contrast agent is carbon dioxide gas. It has been proven safe to use, but the quality of the images it creates needs to be compared to iodine contrast. Patients in this study undergo the endovascular AAA repair as they normally, with the iodine contrast. At the end of surgery carbon dioxide gas contrast is given as an extra step. The images will be later evaluated.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: Carbon dioxide angiogramThere is no control or experimental group. The same patients undergoing endovascular AAA repair with serve as their own control |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Infrarenal abdominal aortic aneurysm amendable to endovascular repair
Key exclusion criteria (1 listed)
- renal failure or contraindication to receiving iodine contrast.
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 |
|---|---|---|
| Carbon dioxide angiogramsee description of procedure | Procedure or surgery | 1 |
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 17 Mar 2017.
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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.
Fred A Weaver, MD principal investigator
University of Southern California
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 Carbon Dioxide and Endovascular Abdominal Aortic Aneurym Repair, run by University of Southern California at 1 site in United States.
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 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: finished, as of the sponsor's last update on 17 Mar 2017. 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 United States. 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?
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 17 Mar 2017.