Gadobutrol Enhanced MRA of the Supra-aortic Vessels (GEMSAV)

Bayer

Status and phase

Completed

Phase 3

Conditions

Carotid Stenosis

Treatments

Drug: Gadobutrol (Gadovist, BAY86-4875)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01344447

14607

2010-023001-36 (EudraCT Number)

Details and patient eligibility

About

Subjects referred for a routine CTA (computed tomography angiography) or MRA (magnetic resonance angiography) will be invited to participate in the study and subjects will be involved in the study for between 2 and 12 days. Two to three visits to the study doctor will be required.

This study will compare the diagnostic results of Gadobutrol enhanced MRA images with MRA images taken without contrast agent using images from a CTA as the standard of reference, which may have been performed up to 60 days prior to enrolment. If a CTA has not been performed in this prior time period, a CTA is required for the study.

MRA and CTA images will be collected for an independent review (blinded read).

Enrollment

479 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female subjects, aged 18 years and older
Any of the following:
- Known or suspected supra-aortic arterial disease based on:
  - Prior stroke
  - Transient ischemic attack (TIA)
  - Amaurosis Fugax (transient monocular blindness)
- Referred for evaluation of any supra-aortic vessel (for clinically significant stenosis)
- Follow-up for a stent in a supra-aortic vessel
- Prior imaging study (CTA or ultrasound) showing ≥ 50% stenosis of a supra-aortic vessel segment (within 60 days before consent). The proportion of subjects with positive disease (determined by the investigator, based on CTA or ultrasound) will be monitored during the study, and enrolment may be further restricted to require ≥ 70% stenosis to ensure that overall there are an adequate number of subjects with clinically significant disease for the evaluation of study endpoints.
Willingness to undergo the routine Contrast Enhanced Magnetic Resonance Angiography [CE MRA] examination with gadobutrol
Willingness and ability to follow directions and complete all study procedures specified in the protocol
Females of childbearing potential only: Negative pregnancy test on the day of the MRA before the administration of study drug

Exclusion criteria

Pregnant or nursing (including pumping for storage and feeding)
Received any other investigational product or participation in any other clinical trial within 30 days before enrollment into this study
Previous enrollment into this study or into any other Bayer sponsored study using gadobutrol
Contraindication to the MRA examinations (e.g. inability to hold breath; severe arrhythmias; very low cardiac output, severe claustrophobia, defibrillators or other metallic devices not approved for MRI)
Contraindication to the use of Gd-containing contrast agents (including subjects with suspicion for or known to have Nephrogenic Systemic Fibrosis [NSF])
History of severe allergic or anaphylactoid reaction to any allergen including drugs and contrast agents
Received any contrast agent within 72 hours before the study MRA, or scheduled receipt of any contrast agent within 24 hours after the study MRA (Note: This applies also to a CTA potentially scheduled during the course of the study.)
Estimated glomerular filtration rate (eGFR) value < 30 ml/min/1.73 m2 derived from a serum creatinine result within 2 weeks before the gadobutrol injection. Any subject on hemodialysis or peritoneal dialysis is excluded from participation. Use the value obtained prior to and closest to the time of the MRA, if there are multiple creatinine values. (Do not use the core lab value if not available prior to the MRA.)
Acute renal insufficiency of any intensity, either due to hepato-renal syndrome or occurring in the peri-operative liver transplantation period
Severe cardiovascular disease (e.g. acute myocardial infarction [< 14 days], unstable angina, congestive heart failure New York Heart Association class IV) or known long QT syndrome
Suspected clinical instability or unpredictability of the clinical course during the study period (e.g. due to previous surgery)
Scheduled or potentially expected for the period between the CTA and gadobutrol MRA:
- Any procedure that may alter the MRA or CTA interpretation, or
- Any interventional or surgical procedure involving the supra-aortic vessels