Comparing Patient Comfort and Safety Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate and compare overall patient comfort profile between an Iso-osmolar contrast media (IOCM), iodixanol 320 mg I/mL, and a Low-osmolar contrast media (LOCM), iopamidol 370 mg I/mL in patients undergoing arteriography of peripheral arteries.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GE Healthcare
• Collaborator: i3 Statprobe

Criteria

Inclusion Criteria:

• The subject is over 18 years old.

• Subjects are referred to undergo a peripheral arteriography as part of their routine clinical care.

Exclusion Criteria:

• The subject has known allergies to iodine or any prior history of adverse reaction to iodinated CM.

• The subject received another administration of CM within 24 hours prior to baseline or is scheduled to receive one within the 24 hour follow-up period.

• The subject is pregnant or lactating.

• The subject is taking metformin (e.g., Glucophage®) but is not willing or unable to discontinue at the time of the study procedure.

• The subject manifests thyrotoxicosis or is on dialysis.