To compare two x-ray contrast agents on their safety and on how patients feel after injecetion into an artery.

• Conditions: Patients that are referred to undergo a peripheral arterigraphy as part of their routine clinical care.; MedDRA version: 14.1Level: PTClassification code 10058049Term: Administration site painSystem Organ Class: 10018065 - General disorders and administration site conditions; MedDRA version: 14.1Level: PTClassification code 10022086Term: Injection site painSystem Organ Class: 10018065 - General disorders and administration site conditions; MedDRA version: 14.1Level: PTClassification code 10013082Term: DiscomfortSystem Organ Class: 10018065 - General disorders and administration site conditions; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2011-000106-22-DE
• Lead Sponsor: GE Healthcare Ltd. and its affiliates

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-10
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

(1)The subject is over 18 years old.

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

(3)The subject has provided signed and dated informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 125
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 125

Exclusion Criteria

(1)The subject has known allergies to iodine or any prior history of adverse reaction to iodinated CM.
(2)The subject received another administration of CM within 24 hours prior to baseline or is scheduled to receive one within 24 hours follow-up period.
(3)The subject is pregnant or lactating.
(4)The subject is taking metformin (e.g., Glucophage®) but is not willing or unable to discontinue at the time of the study procedure.
Note: Metformin must not be taken at least 24 hours prior to the study procedures, withheld for at least 48 hours post-procedure, and restarted only after the subjects renal function has been evaluated and it is deemed safe to resume metformin.
(5)The subject manifests thyrotoxicosis or is on dialysis.

(6)The subject was previously included in this study.

(7)The subject has unstable clinical condition where study participation may compromise the management of the subject or other reason that in the judgment of the investigator makes the subject unsuitable for participation in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified