E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with at least one stenosis of one carotid artery of at least 90% as confirmed by Doppler ultrasound or other radiological methods who are scheduled for i.a. DSA for clinical reasons (or who have received i.a. DSA within 30 days of study inclusion) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10007687 |
E.1.2 | Term | Carotid artery stenosis |
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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 prove the superiority of 0.03 mmol/kg of Vasovist over 0.1 mmol/kg of MultiHance in the depictive representation of the supraaortic vessel segments. |
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E.2.2 | Secondary objectives of the trial |
• To assess the accuracy of Vasovist and MultiHance enhanced MRA for determination of the degree of stenosis using DSA as the standard of reference • To assess the accuracy of Vasovist and MultiHance enhanced MRA for determination of the length of stenosis • To assess the accuracy of Vasovist and MultiHance enhanced MRA for depiction of additional significant stenoses (at least 75%) in all defined vascular segments • To assess SNR and CNR in first pass contrast enhanced MRA • To assess the diagnostic confidence of the combined assessment of first pass and steady state vs. first pass alone of Vasovist enhanced MRA in patients with carotid artery disease
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Adult patients, age 18-85 years 2. At least one at least 90% carotid artery stenosis (confirmed by diagnostic imaging; e.g., Doppler ultrasound, MRA, CT angiography) 3. Willing to undergo all study MRA procedures 4. i.a. DSA of the stenosed carotid artery performed for clinical reasons within 30 days of study inclusion, or i.a. DSA planned for clinical reasons within 30 days of study inclusion 5. Willing to comply with all study procedures (e.g., being interviewed at the end of the adverse event monitoring period 2 hours after the Vasovistīĸ injection) 6. Has voluntarily given written informed consent
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E.4 | Principal exclusion criteria |
1. 1. Women who are pregnant, lactating or who are of childbearing potential and have not had a negative urine pregnancy test the same day as administration of the investigational contrast agent. The manufacturer’s instructions for performing the urinary pregnancy test are to be followed. 2. Patients who are scheduled for any therapy between any of the study procedures that may interfere with the comparability of the angiographic procedures. 3. Having an underlying disease or concomitant medication which may interfere with efficacy or safety evaluations as planned in this study. 4. Having any physical or mental status that interferes with the informed consent procedure including self-signed consent. 5. GFR <60ml/m²/1.73m² (MDRD) as determined from a serum creatinine value not older than 1 week before MR contrast agent injection, or patients on hemodialysis. 6. Renal or liver transplant patients, including patients with scheduled liver transplant are excluded due to the potential risk for nephrogenic systemic fibrosis (NSF). 7. Patients with known severe cardiac arrhythmia. 8. MR contraindications (pacemaker, magnetic clips, severe claustrophobia). 9. Known allergy to Gadofosveset or Gadobenate. 10. Subjects presenting with a history of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents. 11. Having received any investigational drug within 7 days prior to entering this study or who are planned to receive any investigational drug during the 2 hours adverse event monitoring period. 12. Not being able to remain lying down for at least 30-45min (e.g. patients with unstable angina, dyspnea at rest, severe pain at rest, severe back pain). 13. Being clinically unstable and whose clinical course during the 2 hours adverse event monitoring period is unpredictable. 14. Being scheduled for, or likely to require, any surgical intervention within 2 hours before or within the adverse event monitoring period. 15. Close affiliation with the investigational site; e.g. a close relative of the investigator. 16. Participating in another clinical trial. 17. Having been previously enrolled in this clinical trial.
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E.5 End points |
E.5.1 | Primary end point(s) |
visibility of supraaortic vessel segments (patient-based assessment) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
intra-individual comparison |
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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 | Yes |
E.8.2.3.1 | Comparator description |
MultiHance as comperator i.a. DSA as SOR for part of the sec. efficacy criteria |
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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 | 6 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 6 |
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
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Last visit of the last patient. This time point is reached when the 60th valid patient has completed the final assessment at 12 hrs after Vasovist injection. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | |