Conditions: Drug Safety
Keywords: AE - Adverse event Arteriography IA - Intra-arterial IOCM - Iso-Osmolar Contrast Medium LOCM - Low-Osmolar Contrast Medium Patient Comfort Body Image Disturbance Patient
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 255
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Iodixanol intervention 2: Iopamidol
Intervention descriptions: intervention 1: Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration. intervention 2: Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.

Protocol document: