Intra-individual cross-over comparison of MultiHance® and Vasovist® enhanced MRA of the Carotids - Vasovist MRA of the Carotids
- Conditions
- 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)MedDRA version: 9.1Level: LLTClassification code 10007687Term: Carotid artery stenosis
- Registration Number
- EUCTR2008-003669-24-DE
- Lead Sponsor
- Deutsches Krebsforschungszentrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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 Vasovist? injection)
6.Has voluntarily given written informed consent
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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.;Secondary Objective: •To assess the accuracy of Vasovist and MultiHance enhanced MRA for determination of the degree of stenosis using DSA as the standard of reference<br>•To assess the accuracy of Vasovist and MultiHance enhanced MRA for determination of the length of stenosis<br>•To assess the accuracy of Vasovist and MultiHance enhanced MRA for depiction of additional significant stenoses (at least 75%) in all defined vascular segments<br>•To assess SNR and CNR in first pass contrast enhanced MRA<br>•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<br>;Primary end point(s): visibility of supraaortic vessel segments (patient-based assessment)
- Secondary Outcome Measures
Name Time Method