/A

Conditions: The following trial should be performed in patients with a stenosis of supraaortal and intracranial vessels, who are subjected to a plain cranial CT and CT angiography, which is considered to be a standard method in assessing the degree of stenosis.
MedDRA version: 9.1Level: LLTClassification code 10065141Term: Vascular diagnostic procedure

Registration Number: EUCTR2007-001796-11-DE

Lead Sponsor: Institute for Diagnostic Radiology and Neuroradiology, Ernst-Moritz-Arndt University Greifswald

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Age: 18 - 80 years
Scheduled for plain cranial CT and CTA of the supraaortal and intracranial vessels
written informed consent

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

Exclusion Criteria

pregnancy and nursing mothers
additional CT-examinations within the same study
known hypersensitivity to iodine containing contrast agents
known hypersensitivity to Gd-containing contrast agents
hyperthyrodism
advanced renal insufficiency (calculated GFR < 20mL/min)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the image quality and the intravascular enhancement using Gadolinium or iodine containing contrast media.<br>To compare the nephrotoxicity of Gadobutrol (Gadovist®) versus Iodixanol (Visipaque™).;Secondary Objective: ;Primary end point(s): maximum intravascular peak enhancement in Hounsfield units (HU) <br>serum creatinine on day 0 and 3

Secondary Outcome Measures