INTRAINDIVIDUAL CROSS-OVER STUDY TO COMPARE MULTIHANCE® AND MAGNEVIST® AT A DOSE OF 0.1 MMOL/KGBW IN CERVICO-CEREBRAL MR ANGIOGRAPHY AND CEREBRAL MR PERFUSION IMAGING AT 3 TESLA IN PATIENTS WITH CAROTID ARTERY STENOSIS

• Conditions: Carotid artery stenosisandscheduled for MRA, for MR perfusion examination and for an elective stent treatment; MedDRA version: 8.1Level: LLTClassification code 10007687Term: Carotid artery stenosis

• Registration Number: EUCTR2006-000929-59-DE
• Lead Sponsor: Bracco ALTANA Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-22
• Last Update Posted: 1 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patient suffers from a stenosis of the internal carotid artery (ICA), is scheduled for MRA, for MR perfusion examination and for an elective stent treatment;
2. Patient is adult (age, > or =18 years), conscious and co-operative;
3. Patient provides written Informed Consent to participate in the study.
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

1. Patient has a body weight > or = 100 kg;
2. Patients with a severe heart failure (NYHA class IV);
3. Patients with renal insufficiency (creatinine clearance < or = 60 ml/min);
4. Patients with known, hemodynamic stenosis (>60 %) of the contralateral carotid artery;
5. Intra-vascular MR contrast agent procedure within 36 hours preceding each study MR examination;
6. Patient with a history of hypersensitivity to any metals or to chelates of Gadolinium;
7. Significant allergic disposition;
8. Patient with pacemakers, ferro-magnetic material such as surgical clips or any other conditions that would preclude proximity to a strong magnetic field;
9. Patient is suffering from severe claustrophobia;
10. Patient with any medical condition or other circumstances that would significantly decrease the chances of obtaining reliable data or of achieving the study objectives, i.e.:
- drug dependence,
- psychiatric disorder, dementia, or other reasons for expected poor compliance with investigator’s instructions,
- medical conditions, associated illness, or extenuating circumstances that make it highly unlikely that the patient can complete the study;
11. Patient is female and pregnant or nursing;
12. Patient is female and the possibility of pregnancy cannot be excluded from one of the following points:
- surgical sterilization (method has to be recorded on medical history form),
- confirmed post-menopausal (with minimum 1-year history without menstruation),
- negative pregnancy test (confirmed via ß-HCG measurement);
13. Patient is currently participating or has previously participated in a study (in which an investigational drug was dispensed) within 30 days prior to admission to this study;
14. Patient has previously entered this study;
15. Patient without legal capacity (i.e. prisoners).

Study & Design

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