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

This study is currently recruiting participants.
Verified March 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01344447
First received: April 5, 2011
Last updated: April 1, 2014
Last verified: March 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: Allocation: Non-Randomized
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.


Estimated Enrollment: 398
Study Start Date: May 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01344447

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com
Contact: For trial location information (Phone Menu Options '3' or '4') (+)1-888-84 22937

  Hide Study Locations
Locations
United States, Arizona
Recruiting
Tucson, Arizona, United States, 85724
United States, California
Terminated
Newport Beach, California, United States, 92658-6100
United States, Florida
Recruiting
Jacksonville, Florida, United States, 32209
United States, Georgia
Recruiting
Savannah, Georgia, United States, 31406
United States, Kentucky
Completed
Louisville, Kentucky, United States, 40202
United States, Maryland
Recruiting
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Completed
Boston, Massachusetts, United States, 02114
Terminated
Boston, Massachusetts, United States, 02115
United States, Michigan
Recruiting
Ann Arbor, Michigan, United States, 48109-0330
United States, Mississippi
Recruiting
Jackson, Mississippi, United States, 39216
United States, New York
Completed
Bronx, New York, United States, 10467
Terminated
New York, New York, United States, 10032
Recruiting
Rochester, New York, United States, 14642
United States, Ohio
Terminated
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Not yet recruiting
Hershey, Pennsylvania, United States, 17033
Recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
Completed
Providence, Rhode Island, United States, 02903
United States, Tennessee
Recruiting
Memphis, Tennessee, United States, 38104
United States, Washington
Recruiting
Seattle, Washington, United States, 98195
United States, Wisconsin
Completed
Madison, Wisconsin, United States, 53792
Terminated
Milwaukee, Wisconsin, United States, 53215
Argentina
Recruiting
Adrogué, Buenos Aires, Argentina, B1846DWA
Recruiting
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1115AAB
Recruiting
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1425BEE
Not yet recruiting
Rosario, Santa Fe, Argentina, S2000DTC
Australia, New South Wales
Completed
New Lambton Heights, New South Wales, Australia, 2305
Australia, South Australia
Not yet recruiting
Bedford Park, South Australia, Australia, 5042
Australia, Victoria
Recruiting
Clayton, Victoria, Australia, 3168
Recruiting
Parkville, Victoria, Australia, 3052
Austria
Completed
Innsbruck, Tirol, Austria, 6020
Completed
Wien, Austria, 1090
Terminated
Wiener Neustadt, Austria, 2700
Brazil
Terminated
São Paulo, Sao Paulo, Brazil, 05651-900
Terminated
Sao Paulo, Brazil, 05403-900
Terminated
Sao Paulo, Brazil, 01323-001
China
Recruiting
Shanghai, China, 200032
Recruiting
Shanghai, China, 200433
Czech Republic
Recruiting
Brno, Czech Republic, 62500
Not yet recruiting
Plzen, Czech Republic, 304 60
Terminated
Praha 2, Czech Republic, 128 21
Not yet recruiting
Praha 5, Czech Republic, 150 30
France
Recruiting
Brest Cedex, France, 29609
Recruiting
BRON Cedex, France, 69677
Recruiting
Marseille, France, 13385
Recruiting
Paris, France, 75877
Recruiting
Paris Cedex 15, France, 75908
Germany
Recruiting
Karlsruhe, Baden-Württemberg, Germany, 76133
Recruiting
Augsburg, Bayern, Germany, 865156
Recruiting
Erlangen, Bayern, Germany, 91054
Terminated
Frankfurt, Hessen, Germany, 60596
Recruiting
Münster, Nordrhein-Westfalen, Germany, 48145
Terminated
Kiel, Schleswig-Holstein, Germany, 24105
Recruiting
Jena, Thüringen, Germany, 07740
Terminated
Dresden, Germany, 01307
Italy
Recruiting
Lagosanto, Ferrara, Italy, 44023
Recruiting
Massa, Massa-Carrara, Italy, 54100
Recruiting
Mestre, Venezia, Italy, 30174
Recruiting
Aosta, Italy, 11100
Completed
Catania, Italy, 95123
Recruiting
Roma, Italy, 00168
Korea, Republic of
Recruiting
Donggu,, Gwangju Gwang''yeogsi, Korea, Republic of, 501-757
Recruiting
Seoul, Korea, Republic of, 120-752
Recruiting
Seoul, Korea, Republic of, 135-710
Recruiting
Seoul, Korea, Republic of, 138-736
Poland
Recruiting
Bydgoszcz, Poland, 85-094
Recruiting
Lodz, Poland, 90-153
Recruiting
Warszawa, Poland, 02-097
Recruiting
Wroclaw, Poland, 50-556
Terminated
Zamosc, Poland, 22-400
Sweden
Recruiting
Linköping, Sweden, 581 85
Recruiting
Uppsala, Sweden, 751 85
Switzerland
Terminated
Aarau, Aargau, Switzerland, 5001
Completed
St. Gallen, Sankt Gallen, Switzerland, 9007
Terminated
Bern, Switzerland, 3010
Terminated
Luzern, Switzerland, 6000
Turkey
Recruiting
Antalya, Turkey, 07059
Recruiting
Erzurum, Turkey, 25240
Recruiting
Istanbul, Turkey
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: April 1, 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

ClinicalTrials.gov processed this record on April 15, 2014