E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Carotid artery stenosis
and
scheduled for MRA, for MR perfusion examination and for an elective stent treatment |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10007687 |
E.1.2 | Term | Carotid artery stenosis |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To show the superiority of MultiHance® over Magnevist® in the quality of vascular delineation of supraaortic vessels in 3T CE-MRA.
|
|
E.2.2 | Secondary objectives of the trial |
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. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
|
E.4 | Principal 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). |
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E.5 End points |
E.5.1 | 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. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |