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: July 29, 2015
Last verified: July 2015
Results First Received: May 27, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Carotid Stenosis
Intervention: Drug: Gadobutrol (Gadovist, BAY86-4875)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted at 56 study centers in 14 countries, between 12 May 2011 (first participant first visit) and 28 May 2014 (last participant last visit).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 504 participants screened, 17 did not complete screening; due to screen failure in 6, consent withdrawal in 6 and other reasons in 5 participants. Of 487 participants assigned to treatment, 479 received study drug and 8 prematurely terminated due to adverse event in 7 participants, and other reason in 1 participant.

Reporting Groups
  Description
Gadobutrol (Gadavist, BAY 86-4875) Gadobutrol was administered to all participants receiving study drug at the standard dose of 0.1 millimole per kilogram (mmol/kg) body weight (BW) by single intravenous (IV) bolus injection. During the course of the study, non-contrast MRA images were obtained before the administration of gadobutrol, and gadobutrol-enhanced MRA images were obtained after injection.

Participant Flow:   Overall Study
    Gadobutrol (Gadavist, BAY 86-4875)  
STARTED     479 [1]
Fulfilled Requirement of FAS Population     457 [2]
COMPLETED     471  
NOT COMPLETED     8  
Adverse Event                 1  
Protocol Violation                 1  
Withdrawal by Subject                 1  
The contrast was not seen                 1  
Physician Decision                 1  
MRA unsuccessful                 1  
Bolus tracking failed                 1  
Error of power injector                 1  
[1] Participant received study drug; Safety analysis set
[2] Full Analysis Set (FAS)



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Gadobutrol (Gadavist, BAY 86-4875) Gadobutrol was administered to all participants receiving study drug at the standard dose of 0.1 millimole per kilogram (mmol/kg) body weight (BW) by single intravenous (IV) bolus injection. During the course of the study, non-contrast MRA images were obtained before the administration of gadobutrol, and gadobutrol-enhanced MRA images were obtained after injection.

Baseline Measures
    Gadobutrol (Gadavist, BAY 86-4875)  
Number of Participants  
[units: participants]
  479  
Age  
[units: years]
Mean (Standard Deviation)
  68.2  (10)  
Age, Customized  
[units: participants]
 
<45 years     9  
45-64 years     155  
>=65 years     315  
Gender  
[units: participants]
 
Female     167  
Male     312  
Baseline Weight  
[units: kilogram]
Mean (Standard Deviation)
  76.0  (14.5)  



  Outcome Measures
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1.  Primary:   Percentage of Assessable Vascular Segments Using Gadobutrol-Enhanced MRA and Unenhanced MRA   [ Time Frame: Images were taken pre-injection and post-injection ]

2.  Primary:   Sensitivity for Detection of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA   [ Time Frame: Images were taken pre-injection and post-injection ]

3.  Primary:   Specificity for Exclusion of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA   [ Time Frame: Images were taken pre-injection and post-injection ]

4.  Primary:   Minimum Gadobutrol Performance for Sensitivity: Sensitivity > 50%   [ Time Frame: Images were taken pre-injection and post-injection ]

5.  Primary:   Minimum Gadobutrol Performance for Specificity: Specificity > 50%   [ Time Frame: Images were taken pre-injection and post-injection ]

6.  Secondary:   Vessel Diameter (Millimeter [mm]) at the Normal Point and the Narrowest Point in Gadobutrol-Enhanced MRA, Unenhanced MRA and CTA Images   [ Time Frame: Images were taken pre-injection and post-injection ]

7.  Secondary:   The Percentage of Segments With Artifacts Presence   [ Time Frame: Images were taken pre-injection and post-injection ]

8.  Secondary:   Types of Artifacts on a Segment Basis by Blinded Reader 1   [ Time Frame: Images were taken pre-injection and post-injection ]

9.  Secondary:   Types of Artifacts on a Segment Basis by Blinded Reader 2   [ Time Frame: Images were taken pre-injection and post-injection ]

10.  Secondary:   Types of Artifacts on a Segment Basis by Blinded Reader 3   [ Time Frame: Images were taken pre-injection and post-injection ]

11.  Secondary:   The Percentage of Location of Stenosis (>=70%) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA   [ Time Frame: Images were taken pre-injection and post-injection ]

12.  Secondary:   Length of Stenosis (>=70%) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA   [ Time Frame: Images were taken pre-injection and post-injection ]

13.  Secondary:   The Percentage of Presence of Secondary Radiologic Indicators for Diagnosis of Clinically Relevant Disease   [ Time Frame: Images were taken pre-injection and post-injection ]

14.  Secondary:   Type of Secondary Radiologic Indicators for Diagnosis of Clinically Relevant Disease   [ Time Frame: Images were taken pre-injection and post-injection ]

15.  Secondary:   Diagnostic Confidence by the Blinded Readers Using Gadobutrol-Enhanced MRA and Unenhanced MRA   [ Time Frame: Images were taken pre-injection and post-injection ]

16.  Secondary:   The Percentage of Participants With Additional Imaging Studies Recommended by the Blinded Readers and the Clinical Investigator After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images   [ Time Frame: Images were taken pre-injection and post-injection ]

17.  Secondary:   Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images – Blinded Reader 1   [ Time Frame: Images were taken pre-injection and post-injection ]

18.  Secondary:   Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images – Blinded Reader 2   [ Time Frame: Images were taken pre-injection and post-injection ]

19.  Secondary:   Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images – Blinded Reader 3   [ Time Frame: Images were taken pre-injection and post-injection ]

20.  Secondary:   Types of Additional Imaging Studies Recommended by the Clinical Investigator After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images   [ Time Frame: Images were taken pre-injection and post-injection ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Therapeutic Area Head
Organization: BAYER
e-mail: clinical-trials-contact@bayerhealthcare.com


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
Results First Received: May 27, 2015
Last Updated: July 29, 2015
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