Vascular Diseases
Conditions
Keywords
Gadovist, Gadavist, MRI Imaging, vascular diseases, Chinese
Brief summary
The purpose of this study is to determine if the contrast agent is effective and safe in the Magnetic Resonance Imaging (MRI) of vascular diseases in patients of Chinese origin.
Detailed description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.
Interventions
DRUGGadopentate dimeglumine (Magnevist, BAY86-4882)
Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Chinese origin * Known or suspected blood vessel diseases
Exclusion criteria
* Pregnancy * Lactation * Conditions interfering with MRI * Allergy to any contrast agent or any drugs * Participation in other trial * Require emergency treatment * Severely impaired liver and kidney functions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Vessel Segments Visualized With Diagnostic Quality | 20-30 seconds after injection | Each arterial segment visualized in magnetic resonance angiography (MRA) enhanced by Gadavist and Magnevist was characterized by the on-site investigators and by three independent blinded readers (reader 1, 2 and 3) according to a five-point scale (none/not assessable, poor, moderate, good, excellent), which takes into consideration intravascular contrast quality as well as vessel border delineation. The number of vessel segments with adequate diagnostic quality, i.e. good or excellent scores, was determined for each MRA image. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 1 | immediately before and 20-30 seconds after injection (precontrast and postcontrast) | Independent blinded reader 1 assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened. |
| Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 2 | immediately before and 20-30 seconds after injection (precontrast and postcontrast) | Independent blinded reader 2 assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened. |
| Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 3 | immediately before and 20-30 seconds after injection (precontrast and postcontrast) | Independent blinded reader 3 assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened. |
| Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Investigator | immediately before and 20-30 seconds after injection (precontrast and postcontrast) | The on-site investigators assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened. |
| MRA Diagnosis by Blinded Reader 1 | 20-30 seconds after injection | The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis \<= 50% (exemption: internal carotid artery: stenosis \<= 70%), advanced arteriosclerosis, stenosis \>50% but \<99% (stenosis 50-99%) (exemption: internal carotid artery \>70%), occlusion, and not assessable. |
| MRA Diagnosis by Blinded Reader 2 | 20-30 seconds after injection | The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis \<= 50% (exemption: internal carotid artery: stenosis \<= 70%), advanced arteriosclerosis, stenosis \>50% but \<99% (stenosis 50-99%) (exemption: internal carotid artery \>70%), occlusion, and not assessable. |
| MRA Diagnosis by Blinded Reader 3 | 20-30 seconds after injection | The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis \<= 50% (exemption: internal carotid artery: stenosis \<= 70%), advanced arteriosclerosis, stenosis \>50% but \<99% (stenosis 50-99%) (exemption: internal carotid artery \>70%), occlusion, and not assessable. |
| MRA Diagnosis by Investigators | 20-30 seconds after injection | The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis \<= 50% (exemption: internal carotid artery: stenosis \<= 70%), advanced arteriosclerosis, stenosis \>50% but \<99% (stenosis 50-99%) (exemption: internal carotid artery \>70%), occlusion, and not assessable. |
Countries
China
Participant flow
Recruitment details
Participants were recruited at specialized study centers if they satisfied the inclusion and exclusion criteria. All had known or suspected stenosis of arterial vessels in different vascular body regions with an indication for contrast-enhanced magnetic resonance angiography for diagnosis and further treatment.
Pre-assignment details
Of 87 screened participants, 4 were not randomized (2 due to withdrawal of consent, 1 due to entering another clinical study and 1 was lost to follow-up). Thus, 83 participants were randomized to either the sequence Gadobutrol/Gadopentate dimeglumine (41 participants) or Gadopentate dimeglumine/Gadobutrol (42 participants).
Participants by arm
| Arm | Count |
|---|---|
| Period 1: Gadobutrol, Period 2: Gadopentate Dimeglumine Period 1: Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW). Period 2: Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW). | 41 |
| Period 1: Gadopentate Dimeglumine, Period 2: Gadobutrol Period 1: Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW). Period 2: Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW). | 42 |
| Total | 83 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 2 | Adverse Event | 0 | 2 |
| Period 2 | Protocol Violation | 0 | 1 |
| Period 2 | Technical problems | 1 | 0 |
| Period 2 | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Period 1: Gadobutrol, Period 2: Gadopentate Dimeglumine | Period 1: Gadopentate Dimeglumine, Period 2: Gadobutrol | Total |
|---|---|---|---|
| Age, Continuous | 50.8 Years STANDARD_DEVIATION 14.26 | 55.3 Years STANDARD_DEVIATION 11.21 | 53.1 Years STANDARD_DEVIATION 12.93 |
| Sex: Female, Male Female | 14 Participants | 15 Participants | 29 Participants |
| Sex: Female, Male Male | 27 Participants | 27 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 78 | 7 / 81 |
| serious Total, serious adverse events | 0 / 78 | 0 / 81 |
Outcome results
Primary
Number of Vessel Segments Visualized With Diagnostic Quality
Each arterial segment visualized in magnetic resonance angiography (MRA) enhanced by Gadavist and Magnevist was characterized by the on-site investigators and by three independent blinded readers (reader 1, 2 and 3) according to a five-point scale (none/not assessable, poor, moderate, good, excellent), which takes into consideration intravascular contrast quality as well as vessel border delineation. The number of vessel segments with adequate diagnostic quality, i.e. good or excellent scores, was determined for each MRA image.
Time frame: 20-30 seconds after injection
Population: Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases. Note: The contrast enhanced MR image from one participant was lost after assessment by the investigator, i.e. the PPS analysis for the blinded readers is based on the images of 66 participants only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gadobutrol (Gadavist, BAY86-4875) | Number of Vessel Segments Visualized With Diagnostic Quality | Investigators | 8.10 vessel segments | Standard Deviation 3.685 |
| Gadobutrol (Gadavist, BAY86-4875) | Number of Vessel Segments Visualized With Diagnostic Quality | Reader 1 | 8.03 vessel segments | Standard Deviation 3.815 |
| Gadobutrol (Gadavist, BAY86-4875) | Number of Vessel Segments Visualized With Diagnostic Quality | Reader 2 | 7.55 vessel segments | Standard Deviation 4.622 |
| Gadobutrol (Gadavist, BAY86-4875) | Number of Vessel Segments Visualized With Diagnostic Quality | Reader 3 | 5.27 vessel segments | Standard Deviation 3.921 |
| Gadopentate Dimeglumine (Magnevist, BAY86-4882) | Number of Vessel Segments Visualized With Diagnostic Quality | Reader 3 | 5.91 vessel segments | Standard Deviation 3.666 |
| Gadopentate Dimeglumine (Magnevist, BAY86-4882) | Number of Vessel Segments Visualized With Diagnostic Quality | Investigators | 8.33 vessel segments | Standard Deviation 3.755 |
| Gadopentate Dimeglumine (Magnevist, BAY86-4882) | Number of Vessel Segments Visualized With Diagnostic Quality | Reader 2 | 7.88 vessel segments | Standard Deviation 3.665 |
| Gadopentate Dimeglumine (Magnevist, BAY86-4882) | Number of Vessel Segments Visualized With Diagnostic Quality | Reader 1 | 8.33 vessel segments | Standard Deviation 3.852 |
Comparison: Non-inferiority analysis: The aim was to show that Gadavist is not inferior (i.e. similar or better) to Magnevist in visualizing different vascular regions of the body with diagnostic quality in contrast enhanced MRA. Gadavist was to be considered to be non-inferior to Magnevist if the mean number of vessel segments visualized with diagnostic quality of Gadavist enhanced-MRA images was higher than 85% of that of Magnevist enhanced-MRA images in a cross-over design.90% CI: [0.9315, 1.0168]Fieller-type confidence interval
Comparison: Non-inferiority analysis: The aim was to show that Gadavist is not inferior (i.e. similar or better) to Magnevist in visualizing different vascular regions of the body with diagnostic quality in contrast enhanced MRA. Gadavist was to be considered to be non-inferior to Magnevist if the mean number of vessel segments visualized with diagnostic quality of Gadavist enhanced-MRA images was higher than 85% of that of Magnevist enhanced-MRA images in a cross-over design.90% CI: [0.9122, 0.9965]Fieller-type confidence interval
Comparison: Non-inferiority analysis: The aim was to show that Gadavist is not inferior (i.e. similar or better) to Magnevist in visualizing different vascular regions of the body with diagnostic quality in contrast enhanced MRA. Gadavist was to be considered to be non-inferior to Magnevist if the mean number of vessel segments visualized with diagnostic quality of Gadavist enhanced-MRA images was higher than 85% of that of Magnevist enhanced-MRA images in a cross-over design.90% CI: [0.8776, 1.024]Fieller-type confidence interval
Comparison: Non-inferiority analysis: The aim was to show that Gadavist is not inferior (i.e. similar or better) to Magnevist in visualizing different vascular regions of the body with diagnostic quality in contrast enhanced MRA. Gadavist was to be considered to be non-inferior to Magnevist if the mean number of vessel segments visualized with diagnostic quality of Gadavist enhanced-MRA images was higher than 85% of that of Magnevist enhanced-MRA images in a cross-over design.90% CI: [0.78, 0.9657]Fieller-type confidence interval
Secondary
Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 1
Independent blinded reader 1 assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened.
Time frame: immediately before and 20-30 seconds after injection (precontrast and postcontrast)
Population: Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases. Note: The contrast enhanced MR image from one participant was lost after assessment by the investigator, i.e. the PPS analysis for the blinded readers is based on the images of 66 participants only.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol (Gadavist, BAY86-4875) | Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 1 | improved | 61 Participants |
| Gadobutrol (Gadavist, BAY86-4875) | Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 1 | unchanged | 0 Participants |
| Gadobutrol (Gadavist, BAY86-4875) | Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 1 | worsened | 1 Participants |
| Gadobutrol (Gadavist, BAY86-4875) | Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 1 | missing or not applicable | 4 Participants |
| Gadopentate Dimeglumine (Magnevist, BAY86-4882) | Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 1 | missing or not applicable | 3 Participants |
| Gadopentate Dimeglumine (Magnevist, BAY86-4882) | Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 1 | improved | 63 Participants |
| Gadopentate Dimeglumine (Magnevist, BAY86-4882) | Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 1 | worsened | 0 Participants |
| Gadopentate Dimeglumine (Magnevist, BAY86-4882) | Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 1 | unchanged | 0 Participants |
Secondary
Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 2
Independent blinded reader 2 assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened.
Time frame: immediately before and 20-30 seconds after injection (precontrast and postcontrast)
Population: Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases. Note: The contrast enhanced MR image from one participant was lost after assessment by the investigator, i.e. the PPS analysis for the blinded readers is based on the images of 66 participants only.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol (Gadavist, BAY86-4875) | Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 2 | improved | 56 Participants |
| Gadobutrol (Gadavist, BAY86-4875) | Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 2 | unchanged | 3 Participants |
| Gadobutrol (Gadavist, BAY86-4875) | Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 2 | worsened | 1 Participants |
| Gadobutrol (Gadavist, BAY86-4875) | Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 2 | missing or not applicable | 6 Participants |
| Gadopentate Dimeglumine (Magnevist, BAY86-4882) | Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 2 | missing or not applicable | 2 Participants |
| Gadopentate Dimeglumine (Magnevist, BAY86-4882) | Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 2 | improved | 63 Participants |
| Gadopentate Dimeglumine (Magnevist, BAY86-4882) | Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 2 | worsened | 0 Participants |
| Gadopentate Dimeglumine (Magnevist, BAY86-4882) | Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 2 | unchanged | 1 Participants |
Secondary
Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 3
Independent blinded reader 3 assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened.
Time frame: immediately before and 20-30 seconds after injection (precontrast and postcontrast)
Population: Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases. Note: The contrast enhanced MR image from one participant was lost after assessment by the investigator, i.e. the PPS analysis for the blinded readers is based on the images of 66 participants only.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol (Gadavist, BAY86-4875) | Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 3 | improved | 59 Participants |
| Gadobutrol (Gadavist, BAY86-4875) | Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 3 | unchanged | 0 Participants |
| Gadobutrol (Gadavist, BAY86-4875) | Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 3 | worsened | 2 Participants |
| Gadobutrol (Gadavist, BAY86-4875) | Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 3 | missing or not applicable | 5 Participants |
| Gadopentate Dimeglumine (Magnevist, BAY86-4882) | Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 3 | missing or not applicable | 3 Participants |
| Gadopentate Dimeglumine (Magnevist, BAY86-4882) | Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 3 | improved | 63 Participants |
| Gadopentate Dimeglumine (Magnevist, BAY86-4882) | Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 3 | worsened | 0 Participants |
| Gadopentate Dimeglumine (Magnevist, BAY86-4882) | Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 3 | unchanged | 0 Participants |
Secondary
Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Investigator
The on-site investigators assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened.
Time frame: immediately before and 20-30 seconds after injection (precontrast and postcontrast)
Population: Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol (Gadavist, BAY86-4875) | Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Investigator | improved | 63 Participants |
| Gadobutrol (Gadavist, BAY86-4875) | Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Investigator | unchanged | 0 Participants |
| Gadobutrol (Gadavist, BAY86-4875) | Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Investigator | worsened | 0 Participants |
| Gadobutrol (Gadavist, BAY86-4875) | Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Investigator | missing or not applicable | 4 Participants |
| Gadopentate Dimeglumine (Magnevist, BAY86-4882) | Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Investigator | missing or not applicable | 2 Participants |
| Gadopentate Dimeglumine (Magnevist, BAY86-4882) | Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Investigator | improved | 65 Participants |
| Gadopentate Dimeglumine (Magnevist, BAY86-4882) | Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Investigator | worsened | 0 Participants |
| Gadopentate Dimeglumine (Magnevist, BAY86-4882) | Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Investigator | unchanged | 0 Participants |
Secondary
MRA Diagnosis by Blinded Reader 1
The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis \<= 50% (exemption: internal carotid artery: stenosis \<= 70%), advanced arteriosclerosis, stenosis \>50% but \<99% (stenosis 50-99%) (exemption: internal carotid artery \>70%), occlusion, and not assessable.
Time frame: 20-30 seconds after injection
Population: Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases. Note: The contrast enhanced MR image from one participant was lost after assessment by the investigator, i.e. the PPS analysis for the blinded readers is based on the images of 66 participants only.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol (Gadavist, BAY86-4875) | MRA Diagnosis by Blinded Reader 1 | normal | 503 Vessels |
| Gadobutrol (Gadavist, BAY86-4875) | MRA Diagnosis by Blinded Reader 1 | stenosis <= 50% | 33 Vessels |
| Gadobutrol (Gadavist, BAY86-4875) | MRA Diagnosis by Blinded Reader 1 | stenosis > 50% | 22 Vessels |
| Gadobutrol (Gadavist, BAY86-4875) | MRA Diagnosis by Blinded Reader 1 | stenosis <= 70% | 2 Vessels |
| Gadobutrol (Gadavist, BAY86-4875) | MRA Diagnosis by Blinded Reader 1 | stenosis > 70% | 1 Vessels |
| Gadobutrol (Gadavist, BAY86-4875) | MRA Diagnosis by Blinded Reader 1 | not assessable | 272 Vessels |
| Gadobutrol (Gadavist, BAY86-4875) | MRA Diagnosis by Blinded Reader 1 | 100% diameter reduction (occlusion) | 5 Vessels |
| Gadopentate Dimeglumine (Magnevist, BAY86-4882) | MRA Diagnosis by Blinded Reader 1 | normal | 497 Vessels |
| Gadopentate Dimeglumine (Magnevist, BAY86-4882) | MRA Diagnosis by Blinded Reader 1 | stenosis > 70% | 1 Vessels |
| Gadopentate Dimeglumine (Magnevist, BAY86-4882) | MRA Diagnosis by Blinded Reader 1 | stenosis <= 50% | 37 Vessels |
| Gadopentate Dimeglumine (Magnevist, BAY86-4882) | MRA Diagnosis by Blinded Reader 1 | 100% diameter reduction (occlusion) | 5 Vessels |
| Gadopentate Dimeglumine (Magnevist, BAY86-4882) | MRA Diagnosis by Blinded Reader 1 | stenosis > 50% | 24 Vessels |
| Gadopentate Dimeglumine (Magnevist, BAY86-4882) | MRA Diagnosis by Blinded Reader 1 | not assessable | 273 Vessels |
| Gadopentate Dimeglumine (Magnevist, BAY86-4882) | MRA Diagnosis by Blinded Reader 1 | stenosis <= 70% | 1 Vessels |
Secondary
MRA Diagnosis by Blinded Reader 2
The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis \<= 50% (exemption: internal carotid artery: stenosis \<= 70%), advanced arteriosclerosis, stenosis \>50% but \<99% (stenosis 50-99%) (exemption: internal carotid artery \>70%), occlusion, and not assessable.
Time frame: 20-30 seconds after injection
Population: Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases. Note: The contrast enhanced MR image from one participant was lost after assessment by the investigator, i.e. the PPS analysis for the blinded readers is based on the images of 66 participants only.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol (Gadavist, BAY86-4875) | MRA Diagnosis by Blinded Reader 2 | <= 50% stenosis | 83 Vessels |
| Gadobutrol (Gadavist, BAY86-4875) | MRA Diagnosis by Blinded Reader 2 | stenosis <= 70% | 1 Vessels |
| Gadobutrol (Gadavist, BAY86-4875) | MRA Diagnosis by Blinded Reader 2 | normal | 503 Vessels |
| Gadobutrol (Gadavist, BAY86-4875) | MRA Diagnosis by Blinded Reader 2 | stenosis > 70% | 0 Vessels |
| Gadobutrol (Gadavist, BAY86-4875) | MRA Diagnosis by Blinded Reader 2 | > 50% stenosis | 21 Vessels |
| Gadobutrol (Gadavist, BAY86-4875) | MRA Diagnosis by Blinded Reader 2 | not assessable | 215 Vessels |
| Gadobutrol (Gadavist, BAY86-4875) | MRA Diagnosis by Blinded Reader 2 | 100% diameter reduction (occlusion) | 15 Vessels |
| Gadopentate Dimeglumine (Magnevist, BAY86-4882) | MRA Diagnosis by Blinded Reader 2 | not assessable | 224 Vessels |
| Gadopentate Dimeglumine (Magnevist, BAY86-4882) | MRA Diagnosis by Blinded Reader 2 | 100% diameter reduction (occlusion) | 10 Vessels |
| Gadopentate Dimeglumine (Magnevist, BAY86-4882) | MRA Diagnosis by Blinded Reader 2 | normal | 549 Vessels |
| Gadopentate Dimeglumine (Magnevist, BAY86-4882) | MRA Diagnosis by Blinded Reader 2 | <= 50% stenosis | 38 Vessels |
| Gadopentate Dimeglumine (Magnevist, BAY86-4882) | MRA Diagnosis by Blinded Reader 2 | > 50% stenosis | 16 Vessels |
| Gadopentate Dimeglumine (Magnevist, BAY86-4882) | MRA Diagnosis by Blinded Reader 2 | stenosis <= 70% | 1 Vessels |
| Gadopentate Dimeglumine (Magnevist, BAY86-4882) | MRA Diagnosis by Blinded Reader 2 | stenosis > 70% | 0 Vessels |
Secondary
MRA Diagnosis by Blinded Reader 3
The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis \<= 50% (exemption: internal carotid artery: stenosis \<= 70%), advanced arteriosclerosis, stenosis \>50% but \<99% (stenosis 50-99%) (exemption: internal carotid artery \>70%), occlusion, and not assessable.
Time frame: 20-30 seconds after injection
Population: Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases. Note: The contrast enhanced MR image from one participant was lost after assessment by the investigator, i.e. the PPS analysis for the blinded readers is based on the images of 66 participants only.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol (Gadavist, BAY86-4875) | MRA Diagnosis by Blinded Reader 3 | <= 50% stenosis | 8 Vessels |
| Gadobutrol (Gadavist, BAY86-4875) | MRA Diagnosis by Blinded Reader 3 | stenosis <= 70% | 2 Vessels |
| Gadobutrol (Gadavist, BAY86-4875) | MRA Diagnosis by Blinded Reader 3 | normal | 489 Vessels |
| Gadobutrol (Gadavist, BAY86-4875) | MRA Diagnosis by Blinded Reader 3 | stenosis > 70% | 0 Vessels |
| Gadobutrol (Gadavist, BAY86-4875) | MRA Diagnosis by Blinded Reader 3 | > 50% stenosis | 15 Vessels |
| Gadobutrol (Gadavist, BAY86-4875) | MRA Diagnosis by Blinded Reader 3 | not assessable | 321 Vessels |
| Gadobutrol (Gadavist, BAY86-4875) | MRA Diagnosis by Blinded Reader 3 | 100% diameter reduction (occlusion) | 3 Vessels |
| Gadopentate Dimeglumine (Magnevist, BAY86-4882) | MRA Diagnosis by Blinded Reader 3 | not assessable | 308 Vessels |
| Gadopentate Dimeglumine (Magnevist, BAY86-4882) | MRA Diagnosis by Blinded Reader 3 | 100% diameter reduction (occlusion) | 2 Vessels |
| Gadopentate Dimeglumine (Magnevist, BAY86-4882) | MRA Diagnosis by Blinded Reader 3 | normal | 499 Vessels |
| Gadopentate Dimeglumine (Magnevist, BAY86-4882) | MRA Diagnosis by Blinded Reader 3 | <= 50% stenosis | 11 Vessels |
| Gadopentate Dimeglumine (Magnevist, BAY86-4882) | MRA Diagnosis by Blinded Reader 3 | > 50% stenosis | 17 Vessels |
| Gadopentate Dimeglumine (Magnevist, BAY86-4882) | MRA Diagnosis by Blinded Reader 3 | stenosis <= 70% | 1 Vessels |
| Gadopentate Dimeglumine (Magnevist, BAY86-4882) | MRA Diagnosis by Blinded Reader 3 | stenosis > 70% | 0 Vessels |
Secondary
MRA Diagnosis by Investigators
The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis \<= 50% (exemption: internal carotid artery: stenosis \<= 70%), advanced arteriosclerosis, stenosis \>50% but \<99% (stenosis 50-99%) (exemption: internal carotid artery \>70%), occlusion, and not assessable.
Time frame: 20-30 seconds after injection
Population: Per Protocol Set (PPS): All participants who have received contrast injection and are not invalid cases.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol (Gadavist, BAY86-4875) | MRA Diagnosis by Investigators | <= 50% stenosis | 47 Vessels |
| Gadobutrol (Gadavist, BAY86-4875) | MRA Diagnosis by Investigators | stenosis <= 70% | 5 Vessels |
| Gadobutrol (Gadavist, BAY86-4875) | MRA Diagnosis by Investigators | normal | 494 Vessels |
| Gadobutrol (Gadavist, BAY86-4875) | MRA Diagnosis by Investigators | stenosis > 70% | 0 Vessels |
| Gadobutrol (Gadavist, BAY86-4875) | MRA Diagnosis by Investigators | > 50% stenosis | 32 Vessels |
| Gadobutrol (Gadavist, BAY86-4875) | MRA Diagnosis by Investigators | not assessable | 271 Vessels |
| Gadobutrol (Gadavist, BAY86-4875) | MRA Diagnosis by Investigators | 100% diameter reduction (occlusion) | 6 Vessels |
| Gadopentate Dimeglumine (Magnevist, BAY86-4882) | MRA Diagnosis by Investigators | not assessable | 278 Vessels |
| Gadopentate Dimeglumine (Magnevist, BAY86-4882) | MRA Diagnosis by Investigators | 100% diameter reduction (occlusion) | 8 Vessels |
| Gadopentate Dimeglumine (Magnevist, BAY86-4882) | MRA Diagnosis by Investigators | normal | 504 Vessels |
| Gadopentate Dimeglumine (Magnevist, BAY86-4882) | MRA Diagnosis by Investigators | <= 50% stenosis | 30 Vessels |
| Gadopentate Dimeglumine (Magnevist, BAY86-4882) | MRA Diagnosis by Investigators | > 50% stenosis | 32 Vessels |
| Gadopentate Dimeglumine (Magnevist, BAY86-4882) | MRA Diagnosis by Investigators | stenosis <= 70% | 3 Vessels |
| Gadopentate Dimeglumine (Magnevist, BAY86-4882) | MRA Diagnosis by Investigators | stenosis > 70% | 0 Vessels |