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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Southern California
ClinicalTrials.gov Identifier:
NCT00520416
First received: August 22, 2007
Last updated: March 15, 2017
Last verified: March 2017
  Purpose
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 Intervention
Carbon Dioxide
Endovascular Abdominal Aortic Aneurym Repair
Prospective
Angiogram
Procedure: Carbon dioxide angiogram

Study Type: Observational
Study Design: Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Study Start Date: October 2006
Study Completion Date: July 20, 2008
Groups/Cohorts Assigned Interventions
1
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

  Eligibility

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

Inclusion Criteria:

  • Infrarenal abdominal aortic aneurysm amendable to endovascular repair

Exclusion Criteria:

  • renal failure or contraindication to receiving iodine contrast.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00520416

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

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT00520416     History of Changes
Other Study ID Numbers: HS-06-00263
Study First Received: August 22, 2007
Last Updated: March 15, 2017

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

ClinicalTrials.gov processed this record on March 27, 2017