Carotid artery stenosis and scheduled for MRA, for MR perfusion examination and for an elective stent treatment MedDRA version: 8.1 Level: LLT Classification code 10007687 Term: Carotid artery stenosis
Conditions
Sponsors
Bracco ALTANA Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To show the superiority of MultiHance® over Magnevist® in the quality of vascular delineation of supraaortic vessels in 3T CE-MRA. ;Primary end point(s): The individual mean of vessel delineation scores over all evaluable arterial segments (scores 1-5) of a patient as determined in on-site separate assessments of MRA.;Secondary Objective: To compare the contrasting behavior of MultiHance® and Magnevist®: · in 3T CE-MRA with regard to: - Image quality; - Signal intensity measurements; - Determination of the grade and length of the target stenosis (in comparison with DSA results) · in 3T MR perfusion imaging with regard to: - Perfusion quantitative parameters. To compare DSA and 3T CE-MRA (accuracy analysis) in terms of: - Grade of the target stenosis; - Detection/grade of additional stenoses of cerebral arteries. To compare MRI findings pre- and post stent implantation: - Change (normalization) in perfusion deficits; - Delineation of cerebral arteries. | — |
Countries
Germany
Outcome results
None listed