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Prospective, Non-Randomized Evaluation of Carbon Dioxide Gas as a Contrast Agent in Comparison With Iodinated Contrast in Endovascular Aneurysm Repair

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ClinicalTrials.gov Identifier: NCT00520416
Recruitment Status : Completed
First Posted : August 24, 2007
Last Update Posted : March 17, 2017
Information provided by (Responsible Party):
University of Southern California

Brief 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. 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.

Condition or disease Intervention/treatment
Carbon Dioxide Endovascular Abdominal Aortic Aneurym Repair Prospective Angiogram Procedure: Carbon dioxide angiogram

Study Type : Observational
Time Perspective: Prospective
Study Start Date : October 2006
Study Completion Date : July 20, 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
There is no control or experimental group. The same patients undergoing endovascular AAA repair with serve as their own control
Procedure: Carbon dioxide angiogram
see description of procedure

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Infrarenal abdominal aortic aneurysm amendable to endovascular repair

Exclusion Criteria:

  • renal failure or contraindication to receiving iodine contrast.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00520416

United States, California
USC University Hospital
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Principal Investigator: Fred A Weaver, MD University of Southern California

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT00520416     History of Changes
Other Study ID Numbers: HS-06-00263
First Posted: August 24, 2007    Key Record Dates
Last Update Posted: March 17, 2017
Last Verified: March 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No