EUCTR2008-003669-24-DEActive, not recruitingNot Applicable
Intra-individual cross-over comparison of MultiHance® and Vasovist® enhanced MRA of the Carotids - Vasovist MRA of the Carotids
Deutsches Krebsforschungszentrum0 sitesStarted: July 1, 2008Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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 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
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.
Investigators
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