Gadofosveset Trisodium (Vasovist®) zur kontrastverstärkten MR-Angiographie der supraaortalen Arterien und zur Darstellung der Gefäßwand in der primären Kontrastmittelpassage („first pass) und in der intravasalen Phase („steady state) bei 3.OT

Conditions: Comparision between two diagnostic methods (DSA and MRA) to evaluate supraaortale arteries using three different contrast mediums
MedDRA version: 9.1Level: LLTClassification code 10007683Term: Carotid angiography
MedDRA version: 9.1Level: LLTClassification code 10057784Term: MRI angiography
MedDRA version: 9.1Level: LLTClassification code 10065324Term: Digital subtraction angiography

Registration Number: EUCTR2007-003263-52-DE

Lead Sponsor: niversity of Bonn

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

- male and female patients aged 18- 75 years
- written, voluntary informed consent
- patients are able to unterstand the meaning and consequences of the clinical trial
- Indication MRT, MRA/DSA to represent the supraaortale vessels
- GFR > or equal 60 ml/min (Cockroft Gault)
- TSH normal range
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

- MRT is not possible (e.g. cardiac pacemacer, cochlea implant etc.)
- known or suspected pregnancy
- breastfeeding women
- Recent intracerebrale bleeding with suspected aneurysm or AV-malformation (has to be ruled out by CT, native)
- Known anaphylactic or anaphylactoid reaction in history
- life-threatening or haemodynamic instability
- inadequate renal function
- thyroid overactivity or hypothyreoidism
- seizure disorder
- untreated hypocaliaemia
- Known history of HIV infection or chronic hepatitis B or C infection
- participation in any other clinical trial within the last 3 months
- alcohol and/or substance abuse
- patients, who need an emergency therapy/current therapeutic intervention in the area that is to be tested within 24 hours following the initial diagnostics