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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01344447
Recruitment Status : Completed
First Posted : April 29, 2011
Results First Posted : August 26, 2015
Last Update Posted : January 4, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Carotid Stenosis
Intervention Drug: Gadobutrol (Gadovist, BAY86-4875)
Enrollment 479
Recruitment Details 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 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.
Arm/Group Title Gadobutrol (Gadavist, BAY 86-4875)
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 479 [1]
Fulfilled Requirement of FAS Population 457 [2]
Completed 471
Not Completed 8
Reason Not Completed
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)
Arm/Group Title Gadobutrol (Gadavist, BAY 86-4875)
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 479
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 479 participants
68.2  (10)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 479 participants
<45 years 9
45-64 years 155
>=65 years 315
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 479 participants
Female
167
  34.9%
Male
312
  65.1%
Baseline Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram
Number Analyzed 479 participants
76.0  (14.5)
1.Primary Outcome
Title Percentage of Assessable Vascular Segments Using Gadobutrol-Enhanced MRA and Unenhanced MRA
Hide Description Each vascular segment was visualized using unenhanced MRA and gadobutrol-enhanced MRA, characterized by the on-site investigators, three independent blinded readers (BR) (BR 1, BR 2 and BR 3) and majority readers (the outcome determined by at least two of the blinded readers). A segment was assessable if it was visualized along its entire length and if any region of stenosis, was measured reliably. There were 21 segments of the supra-aortic arteries assessed per participant.
Time Frame Images were taken pre-injection and post-injection
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Gadobutrol-enhanced MRA Unenhanced MRA
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 457 457
Overall Number of Units Analyzed
Type of Units Analyzed: Segments
9597 9597
Measure Type: Number
Unit of Measure: percentage of segments
Majority reader 95.0 72.7
Blinded reader 1 88.2 24.4
Blinded reader 2 94.9 75.3
Blinded reader 3 97.4 82.4
Clinical investigators 97.0 78.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gadobutrol-enhanced MRA, Unenhanced MRA
Comments Majority reader; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method McNemar
Comments Cluster adjusted McNemar
Method of Estimation Estimation Parameter Percentage difference
Estimated Value 22.3
Confidence Interval (2-Sided) 95.1%
20.4
Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Gadobutrol-enhanced MRA, Unenhanced MRA
Comments Blinded reader 1; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method McNemar
Comments Cluster adjusted McNemar
Method of Estimation Estimation Parameter Percentage difference
Estimated Value 63.8
Confidence Interval (2-Sided) 95.1%
60.9
Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Gadobutrol-enhanced MRA, Unenhanced MRA
Comments Blinded reader 2; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method McNemar
Comments Cluster adjusted McNemar
Method of Estimation Estimation Parameter Percentage difference
Estimated Value 19.6
Confidence Interval (2-Sided) 95.1%
17.8
Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Gadobutrol-enhanced MRA, Unenhanced MRA
Comments Blinded reader 3; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method McNemar
Comments Cluster adjusted McNemar
Method of Estimation Estimation Parameter Percentage difference
Estimated Value 15.0
Confidence Interval (2-Sided) 95.1%
13.3
Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Gadobutrol-enhanced MRA, Unenhanced MRA
Comments Clinical investigator; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method McNemar
Comments Cluster adjusted McNemar
Method of Estimation Estimation Parameter Percentage difference
Estimated Value 18.5
Confidence Interval (2-Sided) 95.1%
16.5
Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.
Estimation Comments [Not Specified]
2.Primary Outcome
Title Sensitivity for Detection of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA
Hide Description Clinically significant disease was defined as 70 to 99% stenosis of a segment, but not occluded, as assessed by the standard of reference (SoR) (computed tomographic angiography [CTA]; blinded readers). This was determined using the North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria. For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. In case of multiple stenosis in any one segment, the most severe stenosis in the segment was recorded.
Time Frame Images were taken pre-injection and post-injection
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS; in below table, "n/n" signifies the number of participants/segments that were evaluable in specified category of each group.
Arm/Group Title Gadobutrol-enhanced MRA Non-contrast MRA
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 238 238
Overall Number of Units Analyzed
Type of Units Analyzed: Segments
297 297
Measure Type: Number
Unit of Measure: percentage of sensitivity
Majority reader (n=141/158) 60.1 54.4
Blinded reader 1 (n=141/158) 59.5 54.4
Blinded reader 2 (n=141/158) 59.5 54.1
Blinded reader 3 (n=141/158) 58.2 55.7
Clinical investigators (n=238/297) 60.9 39.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gadobutrol-enhanced MRA, Non-contrast MRA
Comments Majority reader; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.
Type of Statistical Test Non-Inferiority or Equivalence
Comments using a -7.5% non-inferiority margin
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method The cluster-adjusted two-sided 95% CI
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage difference
Estimated Value 5.7
Confidence Interval (2-Sided) 95.1%
-3.6
Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Gadobutrol-enhanced MRA, Non-contrast MRA
Comments Blinded reader 1; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.
Type of Statistical Test Non-Inferiority or Equivalence
Comments using a -7.5% non-inferiority margin
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method The cluster-adjusted two-sided 95% CI
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage difference
Estimated Value 5.1
Confidence Interval (2-Sided) 95.1%
-5.4
Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Gadobutrol-enhanced MRA, Non-contrast MRA
Comments Blinded reader 2; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.
Type of Statistical Test Non-Inferiority or Equivalence
Comments using a -7.5% non-inferiority margin
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method The cluster-adjusted two-sided 95% CI
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage difference
Estimated Value 5.1
Confidence Interval (2-Sided) 95.1%
-4.7
Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Gadobutrol-enhanced MRA, Non-contrast MRA
Comments Blinded reader 3; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.
Type of Statistical Test Non-Inferiority or Equivalence
Comments using a -7.5% non-inferiority margin
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method The cluster-adjusted two-sided 95% CI
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage difference
Estimated Value 3.2
Confidence Interval (2-Sided) 95.1%
-5.9
Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Gadobutrol-enhanced MRA, Non-contrast MRA
Comments Clinical investigator; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.
Type of Statistical Test Non-Inferiority or Equivalence
Comments using a -7.5% non-inferiority margin
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method The cluster-adjusted two-sided 95% CI
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage difference
Estimated Value 21.5
Confidence Interval (2-Sided) 95.1%
14.1
Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.
Estimation Comments [Not Specified]
3.Primary Outcome
Title Specificity for Exclusion of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA
Hide Description Clinically significant disease was defined as 70 to 99% stenosis of a segment, but not occluded, as assessed by the SoR (CTA; blinded readers). This was determined using the NASCET criteria. For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. In case of multiple stenosis in any one segment, the most severe stenosis in the segment was recorded.
Time Frame Images were taken pre-injection and post-injection
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS; in below table, "n/n" signifies the number of participants/segments that were evaluable in specified category of each group if it varies from "Number of participants/segments analyzed".
Arm/Group Title Gadobutrol-enhanced MRA Non-contrast MRA
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 457 457
Overall Number of Units Analyzed
Type of Units Analyzed: Segments
9321 9321
Measure Type: Number
Unit of Measure: percentage of specificity
Majority reader (n=457/9321) 96.1 87.3
Blinded reader 1 (n=457/9321) 92.0 61.7
Blinded reader 2 (n=457/9321) 94.7 85.1
Blinded reader 3 (n=457/9321) 96.7 89.1
Clinical investigators (n=457/9133) 98.1 89.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gadobutrol-enhanced MRA, Non-contrast MRA
Comments Majority reader; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.
Type of Statistical Test Non-Inferiority or Equivalence
Comments using a -7.5% non-inferiority margin
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method The cluster-adjusted two-sided 95% CI
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage difference
Estimated Value 8.8
Confidence Interval (2-Sided) 95.1%
7.7
Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Gadobutrol-enhanced MRA, Non-contrast MRA
Comments Blinded reader 1; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.
Type of Statistical Test Non-Inferiority or Equivalence
Comments using a -7.5% non-inferiority margin
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method The cluster-adjusted two-sided 95% CI
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage difference
Estimated Value 30.3
Confidence Interval (2-Sided) 95.1%
28.6
Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Gadobutrol-enhanced MRA, Non-contrast MRA
Comments Blinded reader 2; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.
Type of Statistical Test Non-Inferiority or Equivalence
Comments using a -7.5% non-inferiority margin
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method The cluster-adjusted two-sided 95% CI
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage difference
Estimated Value 9.7
Confidence Interval (2-Sided) 95.1%
8.5
Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Gadobutrol-enhanced MRA, Non-contrast MRA
Comments Blinded reader 3; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.
Type of Statistical Test Non-Inferiority or Equivalence
Comments using a -7.5% non-inferiority margin
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method The cluster-adjusted two-sided 95% CI
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage difference
Estimated Value 7.6
Confidence Interval (2-Sided) 95.1%
6.6
Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Gadobutrol-enhanced MRA, Non-contrast MRA
Comments Clinical investigator; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.
Type of Statistical Test Non-Inferiority or Equivalence
Comments using a -7.5% non-inferiority margin
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method The cluster-adjusted two-sided 95% CI
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage difference
Estimated Value 9.1
Confidence Interval (2-Sided) 95.1%
7.9
Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.
Estimation Comments [Not Specified]
4.Primary Outcome
Title Minimum Gadobutrol Performance for Sensitivity: Sensitivity > 50%
Hide Description Clinically significant disease was defined as 70 to 99% stenosis of a segment, but not occluded as assessed by the SoR (CTA; blinded readers). For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. Gadobutrol minimum performance criteria was based on a stenosis of 50% calculated from the native vessel diameter.
Time Frame Images were taken pre-injection and post-injection
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS; in below table, "n/n" signifies the number of participants/segments that were evaluable in specified category.
Arm/Group Title Gadobutrol-enhanced MRA
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 230
Overall Number of Units Analyzed
Type of Units Analyzed: Segments
283
Measure Type: Number
Unit of Measure: percentage of sensitivity
Majority reader (n=135/149) 61.7
Blinded reader 1 (n=132/146) 60.3
Blinded reader 2 (n=139/156) 59.6
Blinded reader 3 (n=140/155) 58.7
Clinical investigators (n=230/283) 61.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gadobutrol-enhanced MRA
Comments Majority reader
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method One sided 95.1% confidence interval
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage
Estimated Value 61.7
Confidence Interval (1-Sided) 95.1%
55.3
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Gadobutrol-enhanced MRA
Comments Blinded Reader 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method One sided 95.1% confidence interval
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage
Estimated Value 60.3
Confidence Interval (1-Sided) 95.1%
53.6
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Gadobutrol-enhanced MRA
Comments Blinded Reader 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method One sided 95.1% confidence interval
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage
Estimated Value 59.6
Confidence Interval (1-Sided) 95.1%
53.1
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Gadobutrol-enhanced MRA
Comments Blinded Reader 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method One sided 95.1% confidence interval
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage
Estimated Value 58.7
Confidence Interval (1-Sided) 95.1%
52.2
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Gadobutrol-enhanced MRA
Comments Clinical investigator
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method One sided 95.1% confidence interval
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage
Estimated Value 61.5
Confidence Interval (1-Sided) 95.1%
56.7
Estimation Comments [Not Specified]
5.Primary Outcome
Title Minimum Gadobutrol Performance for Specificity: Specificity > 50%
Hide Description Clinically significant disease was defined as 70 to 99% stenosis of a segment, but not occluded as assessed by the SoR (CTA; blinded readers). For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. Gadobutrol minimum performance criteria was based on a stenosis of 50% calculated from the native vessel diameter.
Time Frame Images were taken pre-injection and post-injection
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS; in below table, "n/n" signifies the number of participants/segments that were evaluable in specified category.
Arm/Group Title Gadobutrol-enhanced MRA
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 457
Overall Number of Units Analyzed
Type of Units Analyzed: Segments
8926
Measure Type: Number
Unit of Measure: percentage of specificity
Majority reader (n=457/8805) 98.0
Blinded reader 1 (n=444/8225) 97.6
Blinded reader 2 (n=457/8844) 97.2
Blinded reader 3 (n=457/9079) 98.0
Clinical investigators (n=457/8926) 99.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gadobutrol-enhanced MRA
Comments Majority reader
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method One sided 95.1% confidence interval
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage
Estimated Value 98.0
Confidence Interval (1-Sided) 95.1%
97.7
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Gadobutrol-enhanced MRA
Comments Blinded Reader 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method One sided 95.1% confidence interval
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage
Estimated Value 97.6
Confidence Interval (1-Sided) 95.1%
97.3
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Gadobutrol-enhanced MRA
Comments Blinded Reader 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method One sided 95.1% confidence interval
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage
Estimated Value 97.2
Confidence Interval (1-Sided) 95.1%
96.9
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Gadobutrol-enhanced MRA
Comments Blinded Reader 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method One sided 95.1% confidence interval
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage
Estimated Value 98.0
Confidence Interval (1-Sided) 95.1%
97.7
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Gadobutrol-enhanced MRA
Comments Clinical investigator
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method One sided 95.1% confidence interval
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage
Estimated Value 99.2
Confidence Interval (1-Sided) 95.1%
98.9
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Vessel Diameter (Millimeter [mm]) at the Normal Point and the Narrowest Point in Gadobutrol-Enhanced MRA, Unenhanced MRA and CTA Images
Hide Description The segment reduction in diameter (DIA) of greater than 10% was considered abnormal and measured. The diameter of each of these abnormal segments was measured using electronic calipers (perpendicular to the long axis of the vessel) at the point of most severe stenosis within each segment. Mean of vessel diameters was calculated by segment separately for CTA and MRA readers. For ease of expression, the following abbreviations will be used: Diameter (DIA), Blinded Reader (BR), Clinical Investigator (CI).
Time Frame Images were taken pre-injection and post-injection
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS; Number of participants/segments analyzed in below ordered categories (Normal-BRs; Narrowest-BRs; Normal-CIs; Narrowest-CIs) in Enhanced MRA group was 457/6182, 457/6182, 419/1361, 419/1352 respectively; in Unenhanced MRA group was 455/4776, 455/4776, 367/989, 367/980 respectively; in CTA was 442/3158, 442/3158, 419/1569, 419/1555 respectively.
Arm/Group Title Gadobutrol-Enhanced MRA Unenhanced MRA Computed Tomographic Angiography
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 457 455 442
Mean (Standard Deviation)
Unit of Measure: millimeter(s) (mm)
Vessel DIA at normal point: BRs 4.88  (1.90) 4.33  (1.53) 4.98  (2.08)
Vessel DIA at narrowest point: BRs 3.23  (1.54) 2.66  (1.34) 3.00  (1.50)
Vessel DIA at normal point: CIs 4.81  (1.78) 4.54  (1.58) 5.17  (2.02)
Vessel DIA at narrowest point: CIs 2.42  (1.37) 2.31  (1.21) 2.68  (1.62)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Unenhanced MRA, Computed Tomographic Angiography
Comments CTA Minus Unenhanced MRA for blinded Reader on vessel DIA at normal point
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mean Difference
Comments [Not Specified]
Method of Estimation Estimation Parameter Diameter difference
Estimated Value 0.21
Parameter Dispersion
Type: Standard Deviation
Value: 0.80
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Gadobutrol-Enhanced MRA, Computed Tomographic Angiography
Comments CTA minus Gadobutrol-Enhanced MRA for blinded reader on vessel DIA at normal point
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mean Difference
Comments [Not Specified]
Method of Estimation Estimation Parameter Diameter difference
Estimated Value 0.00
Parameter Dispersion
Type: Standard Deviation
Value: 0.79
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Unenhanced MRA, Computed Tomographic Angiography
Comments CTA minus Unenhanced MRA for blinded reader on vessel DIA at narrowest point
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mean Difference
Comments [Not Specified]
Method of Estimation Estimation Parameter Diameter difference
Estimated Value 0.29
Parameter Dispersion
Type: Standard Deviation
Value: 0.87
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Gadobutrol-Enhanced MRA, Computed Tomographic Angiography
Comments CTA minus Gadobutrol-Enhanced MRA for blinded reader on vessel DIA at narrowest point
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mean Difference
Comments [Not Specified]
Method of Estimation Estimation Parameter Diameter difference
Estimated Value 0.01
Parameter Dispersion
Type: Standard Deviation
Value: 0.80
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Unenhanced MRA, Computed Tomographic Angiography
Comments CTA minus Unenhanced MRA for clinical investigators on vessel DIA at normal point
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mean Difference
Comments [Not Specified]
Method of Estimation Estimation Parameter Diameter difference
Estimated Value 0.48
Parameter Dispersion
Type: Standard Deviation
Value: 0.98
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Gadobutrol-Enhanced MRA, Computed Tomographic Angiography
Comments CTA minus Gadobutrol-enhanced MRA for clinical investigators on vessel DIA at normal point
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mean Difference
Comments [Not Specified]
Method of Estimation Estimation Parameter Diameter difference
Estimated Value 0.33
Parameter Dispersion
Type: Standard Deviation
Value: 1.01
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Unenhanced MRA, Computed Tomographic Angiography
Comments CTA minus Unenhanced MRA for clinical investigators on vessel DIA at narrowest point
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mean Difference
Comments [Not Specified]
Method of Estimation Estimation Parameter Diameter difference
Estimated Value 0.02
Parameter Dispersion
Type: Standard Deviation
Value: 0.81
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Gadobutrol-Enhanced MRA, Computed Tomographic Angiography
Comments CTA minus Gadobutrol-enhanced MRA for clinical investigators on vessel DIA at narrowest point
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mean Difference
Comments [Not Specified]
Method of Estimation Estimation Parameter Diameter difference
Estimated Value 0.11
Parameter Dispersion
Type: Standard Deviation
Value: 0.79
Estimation Comments [Not Specified]
7.Secondary Outcome
Title The Percentage of Segments With Artifacts Presence
Hide Description Artifacts were collected for the MRA images on a segmental basis.
Time Frame Images were taken pre-injection and post-injection
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Evaluable participants in FAS
Arm/Group Title Gadobutrol-enhanced MRA Unenhanced MRA
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 457 457
Overall Number of Units Analyzed
Type of Units Analyzed: Segments
9821 9552
Measure Type: Number
Unit of Measure: percentage of segments
Blinded reader 1 46.6 97.1
Blinded reader 2 14.0 54.9
Blinded reader 3 16.2 41.2
8.Secondary Outcome
Title Types of Artifacts on a Segment Basis by Blinded Reader 1
Hide Description The following types of artifacts were considered: Motion artifact (including pulsatility, breathing, swallowing), venous opacification, saturation artifact (for example [eg], in-plane flow, turbulence, dephasing, saturation band), susceptibility artifacts (including devices, eg, stents), ringing artifact (eg, bands), bolus timing error, and other (artifact not specified above or no artifact).
Time Frame Images were taken pre-injection and post-injection
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in FAS with artifacts presence.
Arm/Group Title Gadobutrol-enhanced MRA Unenhanced MRA
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 457 457
Overall Number of Units Analyzed
Type of Units Analyzed: Segments
9821 9552
Measure Type: Number
Unit of Measure: percentage of segments
Motion artifact 18.6 41.9
Venous opacification 9.8 0.8
Saturation artifact 21.6 38.2
Susceptibility artifacts 0.1 0.2
Ringing artifact 0.5 29.3
Bolus timing error 4.3 4.0
Other 9.3 48.0
9.Secondary Outcome
Title Types of Artifacts on a Segment Basis by Blinded Reader 2
Hide Description The following types of artifacts were considered: Motion artifact (including pulsatility, breathing, swallowing), venous opacification, saturation artifact (for example [eg], in-plane flow, turbulence, dephasing, saturation band), susceptibility artifacts (including devices, eg, stents), ringing artifact (eg, bands), bolus timing error, and other (artifact not specified above or no artifact).
Time Frame Images were taken pre-injection and post-injection
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in FAS with artifacts presence.
Arm/Group Title Gadobutrol-enhanced MRA Unenhanced MRA
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 457 457
Overall Number of Units Analyzed
Type of Units Analyzed: Segments
9821 9552
Measure Type: Number
Unit of Measure: percentage of segments
Motion artifact 5.6 39.8
Venous opacification 5.7 0.3
Saturation artifact 2.0 24.5
Susceptibility artifacts 0.8 3.7
Ringing artifact 0.2 0.0
Bolus timing error 1.1 0.0
Other 0.5 0.3
10.Secondary Outcome
Title Types of Artifacts on a Segment Basis by Blinded Reader 3
Hide Description The following types of artifacts were considered: Motion artifact (including pulsatility, breathing, swallowing), venous opacification, saturation artifact (for example [eg], in-plane flow, turbulence, dephasing, saturation band), susceptibility artifacts (including devices, eg, stents), ringing artifact (eg, bands), bolus timing error, and other (artifact not specified above or no artifact).
Time Frame Images were taken pre-injection and post-injection
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in FAS with artifacts presence.
Arm/Group Title Gadobutrol-enhanced MRA Unenhanced MRA
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 457 457
Overall Number of Units Analyzed
Type of Units Analyzed: Segments
9821 9552
Measure Type: Number
Unit of Measure: percentage of segments
Motion artifact 0.6 13.2
Venous opacification 1.7 0.1
Saturation artifact 13.8 39.4
Susceptibility artifacts 0.2 0.5
Ringing artifact 0.6 6.4
Bolus timing error 1.6 0.4
Other 0.4 0.1
11.Secondary Outcome
Title The Percentage of Location of Stenosis (>=70%) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA
Hide Description Location within a segment was based on the point of greatest stenosis and was recorded for stenosis >=70% (including occlusions) as: - At the bifurcation or proximal origin of a segment (occlusion proximal to the origin of the segment); - Within 5 mm of the bifurcation or proximal origin of a segment; - Beyond 5 mm from the bifurcation or proximal origin of a segment.
Time Frame Images were taken pre-injection and post-injection
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Evaluable participants in FAS; in the below table, "n" signifies number of locations that were evaluable for the specified category of each group.
Arm/Group Title Gadobutrol-enhanced MRA Unenhanced MRA
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 457 457
Measure Type: Number
Unit of Measure: pecentage of location
At the bifurcation: BR 1 (n=353; 89) 50.4 59.6
At the bifurcation: BR 2 (n=429; 429) 52.2 58.7
At the bifurcation: BR 3 (n=525; 559) 44.0 54.2
Within 5 mm of the bifurcation: BR 1 (n=353; 89) 16.7 12.4
Within 5 mm of the bifurcation: BR 2 (n=429; 429) 14.7 10.7
Within 5 mm of the bifurcation: BR 3 (n=525; 559) 34.7 27.0
Beyond 5 mm of the bifurcation: BR 1 (n=353; 89) 32.9 28.1
Beyond 5 mm of the bifurcation: BR 2 (n=429; 429) 33.1 30.5
Beyond 5 mm of the bifurcation: BR 3 (n=525; 559) 21.3 18.8
12.Secondary Outcome
Title Length of Stenosis (>=70%) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA
Hide Description The length of stenosis was based on the most proximal (first point) in a segment where a stenosis exceeded 10% and the most distal point (last point) in the segment where a stenosis exceeded 10%. If a stenosis spanned more than one segment then the measurement was only included to the beginning or end (boundary) of the segment being evaluated. If there was no stenosis of >=70% in a segment then the length was designated as 0.
Time Frame Images were taken pre-injection and post-injection
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Evaluable participants in FAS; this outcome measure was analyzed on a segment basis, in the below table, "n" signifies number of segments that were evaluable for the specified category of each group.
Arm/Group Title Gadobutrol-enhanced MRA Unenhanced MRA
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 457 457
Mean (Standard Deviation)
Unit of Measure: millimeter(s)
Reader 1 (n=290; 66) 11.26  (11.77) 13.36  (11.47)
Reader 2 (n=315; 281) 6.25  (6.99) 7.18  (6.07)
Reader 3 (n=277; 268) 4.89  (4.69) 5.36  (3.76)
13.Secondary Outcome
Title The Percentage of Presence of Secondary Radiologic Indicators for Diagnosis of Clinically Relevant Disease
Hide Description Each segment was assessed for secondary signs of stenosis for diagnosis of clinically significant disease. The following indicators were considered for the MRA studies: - post-stenotic dilation or ulceration (segmental), - post-stenotic signal dropout, narrowing and intensity reduction, and - thrombus. Each of the three parameters were assessed as present or absent in the region distal to the stenosis. If they were found in any segment distal to the stenosis then they were assessed as present.
Time Frame Images were taken pre-injection and post-injection
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Evaluable participants in FAS; this outcome measure was analyzed on a segment basis, in below table, "n" signifies segments that were evaluable for the specified category of each group.
Arm/Group Title Gadobutrol-enhanced MRA Unenhanced MRA
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 457 457
Measure Type: Number
Unit of Measure: percentage of radiologic indicator
Reader 1 (n=9336; 9203) 3.9 0.7
Reader 2 (n=9444; 9177) 2.8 2.0
Reader 3 (n=9285; 9009) 2.4 2.7
14.Secondary Outcome
Title Type of Secondary Radiologic Indicators for Diagnosis of Clinically Relevant Disease
Hide Description Each segment was assessed for secondary signs of stenosis for diagnosis of clinically significant disease. The following indicators were considered for the MRA studies: - post-stenotic dilation or ulceration (segmental), - post-stenotic signal dropout, narrowing and intensity reduction, and - thrombus. Each of the three parameters were assessed as present or absent in the region distal to the stenosis. If they were found in any segment distal to the stenosis then they were assessed as present. If there were tandem (serial) stenosis in a vessel then the secondary signs were assigned to the stenosis of >=70% that was proximal and closest in proximity to the secondary sign.
Time Frame Images were taken pre-injection and post-injection
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Evaluable participants in FAS; this outcome measure was analyzed on a segment basis, in below table, "n" signifies number of segments with presence of secondary radiologic indicators for the specified category of each group.
Arm/Group Title Gadobutrol-enhanced MRA Unenhanced MRA
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 457 457
Measure Type: Number
Unit of Measure: percentage of segments
Post-stenotic dilation: BR 1 (n=390; 63) 49.7 20.6
Post-stenotic dilation: BR 2 (n=271; 188) 74.2 56.4
Post-stenotic dilation: BR 3 (n=236; 246) 7.2 1.6
Post-stenotic signal dropout: BR 1 (n=390; 63) 49.5 77.8
Post-stenotic signal dropout: BR 2 (n=271; 188) 25.5 43.6
Post-stenotic signal dropout: BR 3(n=236; 246) 92.8 98.4
Thrombus: BR 1 (n=390; 63) 0.8 1.6
Thrombus: BR 2 (n=271; 188) 0.4 0.0
Thrombus: BR 3 (n=236; 246) 0.0 0.0
15.Secondary Outcome
Title Diagnostic Confidence by the Blinded Readers Using Gadobutrol-Enhanced MRA and Unenhanced MRA
Hide Description Diagnostic confidence was evaluated to determine the level of certainty that the blinded readers assigned to a diagnosis for each segment. This was defined as the degree of confidence that the information on the MRA images represented the true and complete clinical picture of a particular segment. The degree of confidence was rated on a 4-point scale: 1 = Not confident, 2 = Somewhat confident, 3 = Confident, and 4 = Very confident.
Time Frame Images were taken pre-injection and post-injection
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Evaluable participants in FAS; this outcome measure was analyzed on a segment basis, in below table, "n" signifies number of segments that were evaluable for the specified category of each group.
Arm/Group Title Gadobutrol-enhanced MRA Unenhanced MRA
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 457 456
Mean (Standard Deviation)
Unit of Measure: units on a scale
Reader 1 (n=9408; 9231) 3.2  (1.0) 1.3  (0.6)
Reader 2 (n=9535; 9301) 2.9  (0.6) 2.2  (0.9)
Reader 3 (n=9539; 9302) 2.8  (0.5) 2.4  (0.8)
16.Secondary Outcome
Title 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
Hide Description A measure of diagnostic value was the reduction in the number of additional diagnostic imaging studies recommended/ordered. The clinical investigators and the blinded readers were asked if they would have recommended an additional imaging study for each participant and was recorded.
Time Frame Images were taken pre-injection and post-injection
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Gadobutrol-enhanced MRA Unenhanced MRA
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 457 457
Measure Type: Number
Unit of Measure: percentage of participants
Reader 1 71.1 100.0
Reader 2 44.2 98.2
Reader 3 22.1 83.2
Clinical investigators 11.2 43.1
17.Secondary Outcome
Title Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images – Blinded Reader 1
Hide Description An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.
Time Frame Images were taken pre-injection and post-injection
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in FAS who were recommended for additional imaging studies.
Arm/Group Title Gadobutrol-enhanced MRA Unenhanced MRA
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 325 457
Measure Type: Number
Unit of Measure: participants
Non-contrast MRA 0 0
Contrast-enhanced MRA 64 448
CTA 124 4
Ultrasound 0 0
DSCA 137 5
Nuclear medicine study 0 0
18.Secondary Outcome
Title Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images – Blinded Reader 2
Hide Description An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.
Time Frame Images were taken pre-injection and post-injection
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in FAS who were recommended for additional imaging studies.
Arm/Group Title Gadobutrol-enhanced MRA Unenhanced MRA
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 202 449
Measure Type: Number
Unit of Measure: participants
Non-contrast MRA 50 2
Contrast-enhanced MRA 30 415
CTA 113 30
Ultrasound 0 0
DSCA 9 2
Nuclear medicine study 0 0
19.Secondary Outcome
Title Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images – Blinded Reader 3
Hide Description An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.
Time Frame Images were taken pre-injection and post-injection
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in FAS who were recommended for additional imaging studies.
Arm/Group Title Gadobutrol-enhanced MRA Unenhanced MRA
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 101 380
Measure Type: Number
Unit of Measure: participants
Non-contrast MRA 0 0
Contrast-enhanced MRA 12 64
CTA 88 316
Ultrasound 0 0
DSCA 1 0
Nuclear medicine study 0 0
20.Secondary Outcome
Title Types of Additional Imaging Studies Recommended by the Clinical Investigator After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images
Hide Description An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.
Time Frame Images were taken pre-injection and post-injection
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in FAS who were recommended for additional imaging studies.
Arm/Group Title Gadobutrol-enhanced MRA Unenhanced MRA
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 51 197
Measure Type: Number
Unit of Measure: participants
Non-contrast MRA 1 0
Contrast-enhanced MRA 0 142
CTA 44 51
Ultrasound 1 0
DSCA 5 4
Nuclear medicine study 0 0
Time Frame From the time the consent was signed until 24 (+/-6) hours follow-up after the study MRA but was continued until completion of the CTA in those participants who had the CTA performed after the MRA (as part of the study)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Gadobutrol (Gadavist, BAY 86-4875)
Hide Arm/Group Description 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.
All-Cause Mortality
Gadobutrol (Gadavist, BAY 86-4875)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Gadobutrol (Gadavist, BAY 86-4875)
Affected / at Risk (%)
Total   1/479 (0.21%) 
Nervous system disorders   
Cerebrovascular accident * 1  1/479 (0.21%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (17.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Gadobutrol (Gadavist, BAY 86-4875)
Affected / at Risk (%)
Total   0/479 (0.00%) 
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.
 
Results Point of Contact
Name/Title: Therapeutic Area Head
Organization: BAYER
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01344447     History of Changes
Other Study ID Numbers: 14607
2010-023001-36 ( EudraCT Number )
First Submitted: April 5, 2011
First Posted: April 29, 2011
Results First Submitted: May 27, 2015
Results First Posted: August 26, 2015
Last Update Posted: January 4, 2019