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

General Electric (GE)

Status and phase: Completed; Phase 4

Conditions: Drug Safety

Treatments: Drug: Iopamidol; Drug: Iodixanol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01475097

GE-012-098

Details and patient eligibility

About

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.

Enrollment: 255 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

255 participants in 2 patient groups

Active Arm

Active Comparator group

Treatment:

Drug: Iodixanol

Comparator Arm

Active Comparator group

Treatment:

Drug: Iopamidol