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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01344447
First received: April 5, 2011
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

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).


Condition Intervention Phase
Carotid Stenosis
Drug: Gadobutrol (Gadovist, BAY86-4875)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Multicenter, Open-label Study to Evaluate the Safety and Efficacy (by Blinded Reading) of Contrast-Enhanced Magnetic Resonance Angiography (MRA) After a Single Intravenous Injection of 0.1 mmol/kg Gadobutrol in Subjects With Known or Suspected Vascular Disease of the Supra-aortic Vessels

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Proportion of assessable segments [ Time Frame: Up to 2 weeks ] [ Designated as safety issue: No ]
  • Sensitivity for detection of clinically significant disease (70 to 99% stenosis) on a segmental basis [ Time Frame: Up to 2 weeks ] [ Designated as safety issue: No ]
  • Specificity for exclusion of clinically significant disease (70 to 99% stenosis) on a segmental basis [ Time Frame: Up to 2 weeks ] [ Designated as safety issue: No ]
  • Gadovist minimum performance criteria: Sensitivity > 50% [ Time Frame: Up to 2 weeks ] [ Designated as safety issue: No ]
  • Gadobutrol minimum performance criteria: Specificity > 50% [ Time Frame: Up to 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Minimum diameter of the segment [ Time Frame: Up to 2 weeks ] [ Designated as safety issue: No ]
  • Location and length of stenotic segments with ≥ 70% stenosis [ Time Frame: Up to 2 weeks ] [ Designated as safety issue: No ]
  • Secondary radiologic indicators for diagnosis of clinically significant disease [ Time Frame: Up to 2 weeks ] [ Designated as safety issue: No ]
  • Artifacts by type (segmental) [ Time Frame: Up to 2 weeks ] [ Designated as safety issue: No ]
  • Diagnostic confidence (segmental) [ Time Frame: Up to 2 weeks ] [ Designated as safety issue: No ]
  • Additional imaging studies recommended (example: CTA, CE MRA, Ultrasound, Nuclear Medicine) [ Time Frame: Up to 2 weeks ] [ Designated as safety issue: No ]
    What additional imaging studies would be necessary is a measure of 1) what test provides a definitive diagnosis for treatment decisions and 2) is a direct measure of additional cost a health system would incur for additional imaging studies to reach a definitive diagnosis. This is critical to determining the total cost of imaging for a patient diagnosis in any health system reimbursement structure. Therefore the social/societal cost for not providing a definitive diagnosis with a single imaging study can be determined for health policy and reimbursement decisions.


Enrollment: 481
Study Start Date: May 2011
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Gadobutrol (Gadovist, BAY86-4875)
A single bolus injection of approx. 0.1mmol/kg

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01344447

  Show 78 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01344447     History of Changes
Other Study ID Numbers: 14607, 2010-023001-36
Study First Received: April 5, 2011
Last Updated: June 4, 2014
Health Authority: Argentina: Ministry of Health
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Federal Office for Safety in Health Care
Brazil: Ministry of Health
China: Food and Drug Administration
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Italy: The Italian Medicines Agency
Korea: Food and Drug Administration
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Sweden: Medical Products Agency
Switzerland: Swissmedic
Turkey: Ministry of Health
United States: Food and Drug Administration

Keywords provided by Bayer:
Supra-aortic vascular disease
MRA
CTA
Males and females aged 18 years or older
Stroke
Transient Ischemic Attack (TIA)

Additional relevant MeSH terms:
Carotid Stenosis
Vascular Diseases
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Cardiovascular Diseases
Gadobutrol
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014