Carotid Stenosis
Conditions
Keywords
Supra-aortic vascular disease, MRA, CTA, Males and females aged 18 years or older, Stroke, Transient Ischemic Attack (TIA)
Brief summary
Subjects referred for a routine CTA (computed tomography angiography) or MRA (magnetic resonance angiography) will be invited to participate in the study and subjects will be involved in the study for between 2 and 12 days. Two to three visits to the study doctor will be required. This study will compare the diagnostic results of Gadobutrol enhanced MRA images with MRA images taken without contrast agent using images from a CTA as the standard of reference, which may have been performed up to 60 days prior to enrolment. If a CTA has not been performed in this prior time period, a CTA is required for the study. MRA and CTA images will be collected for an independent review (blinded read).
Interventions
A single bolus injection of approx. 0.1mmol/kg
Sponsors
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female subjects, aged 18 years and older * Any of the following: * Known or suspected supra-aortic arterial disease based on: * Prior stroke * Transient ischemic attack (TIA) * Amaurosis Fugax (transient monocular blindness) * Referred for evaluation of any supra-aortic vessel (for clinically significant stenosis) * Follow-up for a stent in a supra-aortic vessel * Prior imaging study (CTA or ultrasound) showing ≥ 50% stenosis of a supra-aortic vessel segment (within 60 days before consent). The proportion of subjects with positive disease (determined by the investigator, based on CTA or ultrasound) will be monitored during the study, and enrolment may be further restricted to require ≥ 70% stenosis to ensure that overall there are an adequate number of subjects with clinically significant disease for the evaluation of study endpoints. * Willingness to undergo the routine Contrast Enhanced Magnetic Resonance Angiography \[CE MRA\] examination with gadobutrol * Willingness and ability to follow directions and complete all study procedures specified in the protocol * Females of childbearing potential only: Negative pregnancy test on the day of the MRA before the administration of study drug
Exclusion criteria
* Pregnant or nursing (including pumping for storage and feeding) * Received any other investigational product or participation in any other clinical trial within 30 days before enrollment into this study * Previous enrollment into this study or into any other Bayer sponsored study using gadobutrol * Contraindication to the MRA examinations (e.g. inability to hold breath; severe arrhythmias; very low cardiac output, severe claustrophobia, defibrillators or other metallic devices not approved for MRI) * Contraindication to the use of Gd-containing contrast agents (including subjects with suspicion for or known to have Nephrogenic Systemic Fibrosis \[NSF\]) * History of severe allergic or anaphylactoid reaction to any allergen including drugs and contrast agents * Received any contrast agent within 72 hours before the study MRA, or scheduled receipt of any contrast agent within 24 hours after the study MRA (Note: This applies also to a CTA potentially scheduled during the course of the study.) * Estimated glomerular filtration rate (eGFR) value \< 30 ml/min/1.73 m2 derived from a serum creatinine result within 2 weeks before the gadobutrol injection. Any subject on hemodialysis or peritoneal dialysis is excluded from participation. Use the value obtained prior to and closest to the time of the MRA, if there are multiple creatinine values. (Do not use the core lab value if not available prior to the MRA.) * Acute renal insufficiency of any intensity, either due to hepato-renal syndrome or occurring in the peri-operative liver transplantation period * Severe cardiovascular disease (e.g. acute myocardial infarction \[\< 14 days\], unstable angina, congestive heart failure New York Heart Association class IV) or known long QT syndrome * Suspected clinical instability or unpredictability of the clinical course during the study period (e.g. due to previous surgery) * Scheduled or potentially expected for the period between the CTA and gadobutrol MRA: * Any procedure that may alter the MRA or CTA interpretation, or * Any interventional or surgical procedure involving the supra-aortic vessels
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Assessable Vascular Segments Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Images were taken pre-injection and post-injection | 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. |
| Sensitivity for Detection of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Images were taken pre-injection and post-injection | 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. |
| Specificity for Exclusion of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Images were taken pre-injection and post-injection | 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. |
| Minimum Gadobutrol Performance for Sensitivity: Sensitivity > 50% | Images were taken pre-injection and post-injection | 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. |
| Minimum Gadobutrol Performance for Specificity: Specificity > 50% | Images were taken pre-injection and post-injection | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Location of Stenosis (>=70%) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Images were taken pre-injection and post-injection | 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. |
| Length of Stenosis (>=70%) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Images were taken pre-injection and post-injection | 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. |
| The Percentage of Presence of Secondary Radiologic Indicators for Diagnosis of Clinically Relevant Disease | Images were taken pre-injection and post-injection | 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. |
| Type of Secondary Radiologic Indicators for Diagnosis of Clinically Relevant Disease | Images were taken pre-injection and post-injection | 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. |
| Diagnostic Confidence by the Blinded Readers Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Images were taken pre-injection and post-injection | 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. |
| Vessel Diameter (Millimeter [mm]) at the Normal Point and the Narrowest Point in Gadobutrol-Enhanced MRA, Unenhanced MRA and CTA Images | Images were taken pre-injection and post-injection | 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). |
| 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 | Images were taken pre-injection and post-injection | 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. |
| Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 1 | Images were taken pre-injection and post-injection | 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. |
| Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 2 | Images were taken pre-injection and post-injection | 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. |
| Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 3 | Images were taken pre-injection and post-injection | 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. |
| Types of Additional Imaging Studies Recommended by the Clinical Investigator After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images | Images were taken pre-injection and post-injection | 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. |
| The Percentage of Segments With Artifacts Presence | Images were taken pre-injection and post-injection | Artifacts were collected for the MRA images on a segmental basis. |
| Types of Artifacts on a Segment Basis by Blinded Reader 1 | Images were taken pre-injection and post-injection | 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). |
| Types of Artifacts on a Segment Basis by Blinded Reader 2 | Images were taken pre-injection and post-injection | 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). |
| Types of Artifacts on a Segment Basis by Blinded Reader 3 | Images were taken pre-injection and post-injection | 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). |
Countries
Argentina, Australia, Austria, China, Czechia, France, Germany, Italy, Poland, South Korea, Sweden, Switzerland, Turkey (Türkiye), United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 479 |
| Total | 479 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Bolus tracking failed | 1 |
| Overall Study | Error of power injector | 1 |
| Overall Study | MRA unsuccessful | 1 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | The contrast was not seen | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Gadobutrol (Gadavist, BAY 86-4875) |
|---|---|
| Age, Continuous | 68.2 years STANDARD_DEVIATION 10 |
| Age, Customized 45-64 years | 155 participants |
| Age, Customized <45 years | 9 participants |
| Age, Customized >=65 years | 315 participants |
| Baseline Weight | 76.0 kilogram STANDARD_DEVIATION 14.5 |
| Sex: Female, Male Female | 167 Participants |
| Sex: Female, Male Male | 312 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 479 |
| serious Total, serious adverse events | 1 / 479 |
Outcome results
Primary
Minimum Gadobutrol Performance for Sensitivity: Sensitivity > 50%
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
Population: FAS; in below table, n/n signifies the number of participants/segments that were evaluable in specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol-enhanced MRA | Minimum Gadobutrol Performance for Sensitivity: Sensitivity > 50% | Majority reader (n=135/149) | 61.7 percentage of sensitivity |
| Gadobutrol-enhanced MRA | Minimum Gadobutrol Performance for Sensitivity: Sensitivity > 50% | Blinded reader 1 (n=132/146) | 60.3 percentage of sensitivity |
| Gadobutrol-enhanced MRA | Minimum Gadobutrol Performance for Sensitivity: Sensitivity > 50% | Blinded reader 2 (n=139/156) | 59.6 percentage of sensitivity |
| Gadobutrol-enhanced MRA | Minimum Gadobutrol Performance for Sensitivity: Sensitivity > 50% | Blinded reader 3 (n=140/155) | 58.7 percentage of sensitivity |
| Gadobutrol-enhanced MRA | Minimum Gadobutrol Performance for Sensitivity: Sensitivity > 50% | Clinical investigators (n=230/283) | 61.5 percentage of sensitivity |
Comparison: Majority readerOne sided 95.1% confidence interval
Comparison: Blinded Reader 1One sided 95.1% confidence interval
Comparison: Blinded Reader 2One sided 95.1% confidence interval
Comparison: Blinded Reader 3One sided 95.1% confidence interval
Comparison: Clinical investigatorOne sided 95.1% confidence interval
Primary
Minimum Gadobutrol Performance for Specificity: Specificity > 50%
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
Population: FAS; in below table, n/n signifies the number of participants/segments that were evaluable in specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol-enhanced MRA | Minimum Gadobutrol Performance for Specificity: Specificity > 50% | Majority reader (n=457/8805) | 98.0 percentage of specificity |
| Gadobutrol-enhanced MRA | Minimum Gadobutrol Performance for Specificity: Specificity > 50% | Blinded reader 1 (n=444/8225) | 97.6 percentage of specificity |
| Gadobutrol-enhanced MRA | Minimum Gadobutrol Performance for Specificity: Specificity > 50% | Blinded reader 2 (n=457/8844) | 97.2 percentage of specificity |
| Gadobutrol-enhanced MRA | Minimum Gadobutrol Performance for Specificity: Specificity > 50% | Blinded reader 3 (n=457/9079) | 98.0 percentage of specificity |
| Gadobutrol-enhanced MRA | Minimum Gadobutrol Performance for Specificity: Specificity > 50% | Clinical investigators (n=457/8926) | 99.2 percentage of specificity |
Comparison: Majority readerOne sided 95.1% confidence interval
Comparison: Blinded Reader 1One sided 95.1% confidence interval
Comparison: Blinded Reader 2One sided 95.1% confidence interval
Comparison: Blinded Reader 3One sided 95.1% confidence interval
Comparison: Clinical investigatorOne sided 95.1% confidence interval
Primary
Percentage of Assessable Vascular Segments Using Gadobutrol-Enhanced MRA and Unenhanced MRA
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
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol-enhanced MRA | Percentage of Assessable Vascular Segments Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Majority reader | 95.0 percentage of segments |
| Gadobutrol-enhanced MRA | Percentage of Assessable Vascular Segments Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Blinded reader 1 | 88.2 percentage of segments |
| Gadobutrol-enhanced MRA | Percentage of Assessable Vascular Segments Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Blinded reader 2 | 94.9 percentage of segments |
| Gadobutrol-enhanced MRA | Percentage of Assessable Vascular Segments Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Blinded reader 3 | 97.4 percentage of segments |
| Gadobutrol-enhanced MRA | Percentage of Assessable Vascular Segments Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Clinical investigators | 97.0 percentage of segments |
| Unenhanced MRA | Percentage of Assessable Vascular Segments Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Clinical investigators | 78.6 percentage of segments |
| Unenhanced MRA | Percentage of Assessable Vascular Segments Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Blinded reader 3 | 82.4 percentage of segments |
| Unenhanced MRA | Percentage of Assessable Vascular Segments Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Blinded reader 1 | 24.4 percentage of segments |
| Unenhanced MRA | Percentage of Assessable Vascular Segments Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Majority reader | 72.7 percentage of segments |
| Unenhanced MRA | Percentage of Assessable Vascular Segments Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Blinded reader 2 | 75.3 percentage of segments |
Comparison: Majority reader; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.p-value: <0.0001McNemar
Comparison: Blinded reader 1; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.p-value: <0.0001McNemar
Comparison: Blinded reader 2; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.p-value: <0.0001McNemar
Comparison: Blinded reader 3; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.p-value: <0.0001McNemar
Comparison: Clinical investigator; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.p-value: <0.0001McNemar
Primary
Sensitivity for Detection of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA
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
Population: FAS; in below table, n/n signifies the number of participants/segments that were evaluable in specified category of each group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol-enhanced MRA | Sensitivity for Detection of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Blinded reader 1 (n=141/158) | 59.5 percentage of sensitivity |
| Gadobutrol-enhanced MRA | Sensitivity for Detection of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Blinded reader 3 (n=141/158) | 58.2 percentage of sensitivity |
| Gadobutrol-enhanced MRA | Sensitivity for Detection of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Blinded reader 2 (n=141/158) | 59.5 percentage of sensitivity |
| Gadobutrol-enhanced MRA | Sensitivity for Detection of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Clinical investigators (n=238/297) | 60.9 percentage of sensitivity |
| Gadobutrol-enhanced MRA | Sensitivity for Detection of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Majority reader (n=141/158) | 60.1 percentage of sensitivity |
| Unenhanced MRA | Sensitivity for Detection of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Clinical investigators (n=238/297) | 39.4 percentage of sensitivity |
| Unenhanced MRA | Sensitivity for Detection of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Majority reader (n=141/158) | 54.4 percentage of sensitivity |
| Unenhanced MRA | Sensitivity for Detection of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Blinded reader 1 (n=141/158) | 54.4 percentage of sensitivity |
| Unenhanced MRA | Sensitivity for Detection of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Blinded reader 2 (n=141/158) | 54.1 percentage of sensitivity |
| Unenhanced MRA | Sensitivity for Detection of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Blinded reader 3 (n=141/158) | 55.7 percentage of sensitivity |
Comparison: Majority reader; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.The cluster-adjusted two-sided 95% CI
Comparison: Blinded reader 1; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.The cluster-adjusted two-sided 95% CI
Comparison: Blinded reader 2; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.The cluster-adjusted two-sided 95% CI
Comparison: Blinded reader 3; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.The cluster-adjusted two-sided 95% CI
Comparison: Clinical investigator; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.The cluster-adjusted two-sided 95% CI
Primary
Specificity for Exclusion of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol-enhanced MRA | Specificity for Exclusion of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Blinded reader 1 (n=457/9321) | 92.0 percentage of specificity |
| Gadobutrol-enhanced MRA | Specificity for Exclusion of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Blinded reader 3 (n=457/9321) | 96.7 percentage of specificity |
| Gadobutrol-enhanced MRA | Specificity for Exclusion of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Blinded reader 2 (n=457/9321) | 94.7 percentage of specificity |
| Gadobutrol-enhanced MRA | Specificity for Exclusion of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Clinical investigators (n=457/9133) | 98.1 percentage of specificity |
| Gadobutrol-enhanced MRA | Specificity for Exclusion of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Majority reader (n=457/9321) | 96.1 percentage of specificity |
| Unenhanced MRA | Specificity for Exclusion of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Clinical investigators (n=457/9133) | 89.1 percentage of specificity |
| Unenhanced MRA | Specificity for Exclusion of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Majority reader (n=457/9321) | 87.3 percentage of specificity |
| Unenhanced MRA | Specificity for Exclusion of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Blinded reader 1 (n=457/9321) | 61.7 percentage of specificity |
| Unenhanced MRA | Specificity for Exclusion of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Blinded reader 2 (n=457/9321) | 85.1 percentage of specificity |
| Unenhanced MRA | Specificity for Exclusion of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Blinded reader 3 (n=457/9321) | 89.1 percentage of specificity |
Comparison: Majority reader; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.The cluster-adjusted two-sided 95% CI
Comparison: Blinded reader 1; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.The cluster-adjusted two-sided 95% CI
Comparison: Blinded reader 2; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.The cluster-adjusted two-sided 95% CI
Comparison: Blinded reader 3; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.The cluster-adjusted two-sided 95% CI
Comparison: Clinical investigator; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.The cluster-adjusted two-sided 95% CI
Secondary
Diagnostic Confidence by the Blinded Readers Using Gadobutrol-Enhanced MRA and Unenhanced MRA
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gadobutrol-enhanced MRA | Diagnostic Confidence by the Blinded Readers Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Reader 1 (n=9408; 9231) | 3.2 units on a scale | Standard Deviation 1 |
| Gadobutrol-enhanced MRA | Diagnostic Confidence by the Blinded Readers Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Reader 2 (n=9535; 9301) | 2.9 units on a scale | Standard Deviation 0.6 |
| Gadobutrol-enhanced MRA | Diagnostic Confidence by the Blinded Readers Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Reader 3 (n=9539; 9302) | 2.8 units on a scale | Standard Deviation 0.5 |
| Unenhanced MRA | Diagnostic Confidence by the Blinded Readers Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Reader 1 (n=9408; 9231) | 1.3 units on a scale | Standard Deviation 0.6 |
| Unenhanced MRA | Diagnostic Confidence by the Blinded Readers Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Reader 2 (n=9535; 9301) | 2.2 units on a scale | Standard Deviation 0.9 |
| Unenhanced MRA | Diagnostic Confidence by the Blinded Readers Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Reader 3 (n=9539; 9302) | 2.4 units on a scale | Standard Deviation 0.8 |
Secondary
Length of Stenosis (>=70%) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gadobutrol-enhanced MRA | Length of Stenosis (>=70%) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Reader 1 (n=290; 66) | 11.26 millimeter(s) | Standard Deviation 11.77 |
| Gadobutrol-enhanced MRA | Length of Stenosis (>=70%) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Reader 2 (n=315; 281) | 6.25 millimeter(s) | Standard Deviation 6.99 |
| Gadobutrol-enhanced MRA | Length of Stenosis (>=70%) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Reader 3 (n=277; 268) | 4.89 millimeter(s) | Standard Deviation 4.69 |
| Unenhanced MRA | Length of Stenosis (>=70%) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Reader 3 (n=277; 268) | 5.36 millimeter(s) | Standard Deviation 3.76 |
| Unenhanced MRA | Length of Stenosis (>=70%) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Reader 1 (n=290; 66) | 13.36 millimeter(s) | Standard Deviation 11.47 |
| Unenhanced MRA | Length of Stenosis (>=70%) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Reader 2 (n=315; 281) | 7.18 millimeter(s) | Standard Deviation 6.07 |
Secondary
The Percentage of Location of Stenosis (>=70%) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA
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
Population: Evaluable participants in FAS; in the below table, n signifies number of locations that were evaluable for the specified category of each group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol-enhanced MRA | The Percentage of Location of Stenosis (>=70%) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | At the bifurcation: BR 2 (n=429; 429) | 52.2 pecentage of location |
| Gadobutrol-enhanced MRA | The Percentage of Location of Stenosis (>=70%) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Within 5 mm of the bifurcation: BR 3 (n=525; 559) | 34.7 pecentage of location |
| Gadobutrol-enhanced MRA | The Percentage of Location of Stenosis (>=70%) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Within 5 mm of the bifurcation: BR 1 (n=353; 89) | 16.7 pecentage of location |
| Gadobutrol-enhanced MRA | The Percentage of Location of Stenosis (>=70%) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Beyond 5 mm of the bifurcation: BR 1 (n=353; 89) | 32.9 pecentage of location |
| Gadobutrol-enhanced MRA | The Percentage of Location of Stenosis (>=70%) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | At the bifurcation: BR 3 (n=525; 559) | 44.0 pecentage of location |
| Gadobutrol-enhanced MRA | The Percentage of Location of Stenosis (>=70%) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Beyond 5 mm of the bifurcation: BR 2 (n=429; 429) | 33.1 pecentage of location |
| Gadobutrol-enhanced MRA | The Percentage of Location of Stenosis (>=70%) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Within 5 mm of the bifurcation: BR 2 (n=429; 429) | 14.7 pecentage of location |
| Gadobutrol-enhanced MRA | The Percentage of Location of Stenosis (>=70%) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Beyond 5 mm of the bifurcation: BR 3 (n=525; 559) | 21.3 pecentage of location |
| Gadobutrol-enhanced MRA | The Percentage of Location of Stenosis (>=70%) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | At the bifurcation: BR 1 (n=353; 89) | 50.4 pecentage of location |
| Unenhanced MRA | The Percentage of Location of Stenosis (>=70%) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Beyond 5 mm of the bifurcation: BR 3 (n=525; 559) | 18.8 pecentage of location |
| Unenhanced MRA | The Percentage of Location of Stenosis (>=70%) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | At the bifurcation: BR 1 (n=353; 89) | 59.6 pecentage of location |
| Unenhanced MRA | The Percentage of Location of Stenosis (>=70%) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | At the bifurcation: BR 2 (n=429; 429) | 58.7 pecentage of location |
| Unenhanced MRA | The Percentage of Location of Stenosis (>=70%) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | At the bifurcation: BR 3 (n=525; 559) | 54.2 pecentage of location |
| Unenhanced MRA | The Percentage of Location of Stenosis (>=70%) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Within 5 mm of the bifurcation: BR 1 (n=353; 89) | 12.4 pecentage of location |
| Unenhanced MRA | The Percentage of Location of Stenosis (>=70%) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Within 5 mm of the bifurcation: BR 2 (n=429; 429) | 10.7 pecentage of location |
| Unenhanced MRA | The Percentage of Location of Stenosis (>=70%) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Within 5 mm of the bifurcation: BR 3 (n=525; 559) | 27.0 pecentage of location |
| Unenhanced MRA | The Percentage of Location of Stenosis (>=70%) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Beyond 5 mm of the bifurcation: BR 1 (n=353; 89) | 28.1 pecentage of location |
| Unenhanced MRA | The Percentage of Location of Stenosis (>=70%) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Beyond 5 mm of the bifurcation: BR 2 (n=429; 429) | 30.5 pecentage of location |
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
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
Population: FAS
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Gadobutrol-enhanced MRA | 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 | Reader 1 | 71.1 percentage of participants | 11.77 |
| Gadobutrol-enhanced MRA | 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 | Reader 2 | 44.2 percentage of participants | 6.99 |
| Gadobutrol-enhanced MRA | 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 | Reader 3 | 22.1 percentage of participants | 4.69 |
| Gadobutrol-enhanced MRA | 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 | Clinical investigators | 11.2 percentage of participants | — |
| Unenhanced MRA | 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 | Clinical investigators | 43.1 percentage of participants | — |
| Unenhanced MRA | 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 | Reader 1 | 100.0 percentage of participants | 11.47 |
| Unenhanced MRA | 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 | Reader 3 | 83.2 percentage of participants | 3.76 |
| Unenhanced MRA | 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 | Reader 2 | 98.2 percentage of participants | 6.07 |
Secondary
The Percentage of Presence of Secondary Radiologic Indicators for Diagnosis of Clinically Relevant Disease
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
Population: 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 | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Gadobutrol-enhanced MRA | The Percentage of Presence of Secondary Radiologic Indicators for Diagnosis of Clinically Relevant Disease | Reader 1 (n=9336; 9203) | 3.9 percentage of radiologic indicator | 11.77 |
| Gadobutrol-enhanced MRA | The Percentage of Presence of Secondary Radiologic Indicators for Diagnosis of Clinically Relevant Disease | Reader 2 (n=9444; 9177) | 2.8 percentage of radiologic indicator | 6.99 |
| Gadobutrol-enhanced MRA | The Percentage of Presence of Secondary Radiologic Indicators for Diagnosis of Clinically Relevant Disease | Reader 3 (n=9285; 9009) | 2.4 percentage of radiologic indicator | 4.69 |
| Unenhanced MRA | The Percentage of Presence of Secondary Radiologic Indicators for Diagnosis of Clinically Relevant Disease | Reader 1 (n=9336; 9203) | 0.7 percentage of radiologic indicator | 11.47 |
| Unenhanced MRA | The Percentage of Presence of Secondary Radiologic Indicators for Diagnosis of Clinically Relevant Disease | Reader 2 (n=9444; 9177) | 2.0 percentage of radiologic indicator | 6.07 |
| Unenhanced MRA | The Percentage of Presence of Secondary Radiologic Indicators for Diagnosis of Clinically Relevant Disease | Reader 3 (n=9285; 9009) | 2.7 percentage of radiologic indicator | 3.76 |
Secondary
The Percentage of Segments With Artifacts Presence
Artifacts were collected for the MRA images on a segmental basis.
Time frame: Images were taken pre-injection and post-injection
Population: Evaluable participants in FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol-enhanced MRA | The Percentage of Segments With Artifacts Presence | Blinded reader 1 | 46.6 percentage of segments |
| Gadobutrol-enhanced MRA | The Percentage of Segments With Artifacts Presence | Blinded reader 2 | 14.0 percentage of segments |
| Gadobutrol-enhanced MRA | The Percentage of Segments With Artifacts Presence | Blinded reader 3 | 16.2 percentage of segments |
| Unenhanced MRA | The Percentage of Segments With Artifacts Presence | Blinded reader 1 | 97.1 percentage of segments |
| Unenhanced MRA | The Percentage of Segments With Artifacts Presence | Blinded reader 2 | 54.9 percentage of segments |
| Unenhanced MRA | The Percentage of Segments With Artifacts Presence | Blinded reader 3 | 41.2 percentage of segments |
Secondary
Type of Secondary Radiologic Indicators for Diagnosis of Clinically Relevant Disease
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
Population: 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 | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Gadobutrol-enhanced MRA | Type of Secondary Radiologic Indicators for Diagnosis of Clinically Relevant Disease | Post-stenotic dilation: BR 1 (n=390; 63) | 49.7 percentage of segments | 11.77 |
| Gadobutrol-enhanced MRA | Type of Secondary Radiologic Indicators for Diagnosis of Clinically Relevant Disease | Post-stenotic dilation: BR 2 (n=271; 188) | 74.2 percentage of segments | 6.99 |
| Gadobutrol-enhanced MRA | Type of Secondary Radiologic Indicators for Diagnosis of Clinically Relevant Disease | Post-stenotic dilation: BR 3 (n=236; 246) | 7.2 percentage of segments | 4.69 |
| Gadobutrol-enhanced MRA | Type of Secondary Radiologic Indicators for Diagnosis of Clinically Relevant Disease | Post-stenotic signal dropout: BR 1 (n=390; 63) | 49.5 percentage of segments | — |
| Gadobutrol-enhanced MRA | Type of Secondary Radiologic Indicators for Diagnosis of Clinically Relevant Disease | Post-stenotic signal dropout: BR 2 (n=271; 188) | 25.5 percentage of segments | — |
| Gadobutrol-enhanced MRA | Type of Secondary Radiologic Indicators for Diagnosis of Clinically Relevant Disease | Thrombus: BR 3 (n=236; 246) | 0.0 percentage of segments | — |
| Gadobutrol-enhanced MRA | Type of Secondary Radiologic Indicators for Diagnosis of Clinically Relevant Disease | Post-stenotic signal dropout: BR 3(n=236; 246) | 92.8 percentage of segments | — |
| Gadobutrol-enhanced MRA | Type of Secondary Radiologic Indicators for Diagnosis of Clinically Relevant Disease | Thrombus: BR 1 (n=390; 63) | 0.8 percentage of segments | — |
| Gadobutrol-enhanced MRA | Type of Secondary Radiologic Indicators for Diagnosis of Clinically Relevant Disease | Thrombus: BR 2 (n=271; 188) | 0.4 percentage of segments | — |
| Unenhanced MRA | Type of Secondary Radiologic Indicators for Diagnosis of Clinically Relevant Disease | Thrombus: BR 1 (n=390; 63) | 1.6 percentage of segments | — |
| Unenhanced MRA | Type of Secondary Radiologic Indicators for Diagnosis of Clinically Relevant Disease | Post-stenotic dilation: BR 1 (n=390; 63) | 20.6 percentage of segments | 11.47 |
| Unenhanced MRA | Type of Secondary Radiologic Indicators for Diagnosis of Clinically Relevant Disease | Post-stenotic signal dropout: BR 2 (n=271; 188) | 43.6 percentage of segments | — |
| Unenhanced MRA | Type of Secondary Radiologic Indicators for Diagnosis of Clinically Relevant Disease | Post-stenotic dilation: BR 2 (n=271; 188) | 56.4 percentage of segments | 6.07 |
| Unenhanced MRA | Type of Secondary Radiologic Indicators for Diagnosis of Clinically Relevant Disease | Thrombus: BR 3 (n=236; 246) | 0.0 percentage of segments | — |
| Unenhanced MRA | Type of Secondary Radiologic Indicators for Diagnosis of Clinically Relevant Disease | Post-stenotic dilation: BR 3 (n=236; 246) | 1.6 percentage of segments | 3.76 |
| Unenhanced MRA | Type of Secondary Radiologic Indicators for Diagnosis of Clinically Relevant Disease | Post-stenotic signal dropout: BR 3(n=236; 246) | 98.4 percentage of segments | — |
| Unenhanced MRA | Type of Secondary Radiologic Indicators for Diagnosis of Clinically Relevant Disease | Post-stenotic signal dropout: BR 1 (n=390; 63) | 77.8 percentage of segments | — |
| Unenhanced MRA | Type of Secondary Radiologic Indicators for Diagnosis of Clinically Relevant Disease | Thrombus: BR 2 (n=271; 188) | 0.0 percentage of segments | — |
Secondary
Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 1
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
Population: Participants in FAS who were recommended for additional imaging studies.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Gadobutrol-enhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 1 | Non-contrast MRA | 0 participants | 11.77 |
| Gadobutrol-enhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 1 | Contrast-enhanced MRA | 64 participants | 6.99 |
| Gadobutrol-enhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 1 | CTA | 124 participants | 4.69 |
| Gadobutrol-enhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 1 | Ultrasound | 0 participants | — |
| Gadobutrol-enhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 1 | DSCA | 137 participants | — |
| Gadobutrol-enhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 1 | Nuclear medicine study | 0 participants | — |
| Unenhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 1 | DSCA | 5 participants | — |
| Unenhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 1 | Non-contrast MRA | 0 participants | 11.47 |
| Unenhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 1 | Ultrasound | 0 participants | — |
| Unenhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 1 | Contrast-enhanced MRA | 448 participants | 6.07 |
| Unenhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 1 | Nuclear medicine study | 0 participants | — |
| Unenhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 1 | CTA | 4 participants | 3.76 |
Secondary
Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 2
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
Population: Participants in FAS who were recommended for additional imaging studies.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Gadobutrol-enhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 2 | Non-contrast MRA | 50 participants | 11.77 |
| Gadobutrol-enhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 2 | Contrast-enhanced MRA | 30 participants | 6.99 |
| Gadobutrol-enhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 2 | CTA | 113 participants | 4.69 |
| Gadobutrol-enhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 2 | Ultrasound | 0 participants | — |
| Gadobutrol-enhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 2 | DSCA | 9 participants | — |
| Gadobutrol-enhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 2 | Nuclear medicine study | 0 participants | — |
| Unenhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 2 | DSCA | 2 participants | — |
| Unenhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 2 | Non-contrast MRA | 2 participants | 11.47 |
| Unenhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 2 | Ultrasound | 0 participants | — |
| Unenhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 2 | Contrast-enhanced MRA | 415 participants | 6.07 |
| Unenhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 2 | Nuclear medicine study | 0 participants | — |
| Unenhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 2 | CTA | 30 participants | 3.76 |
Secondary
Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 3
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
Population: Participants in FAS who were recommended for additional imaging studies.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Gadobutrol-enhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 3 | Ultrasound | 0 participants | — |
| Gadobutrol-enhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 3 | Non-contrast MRA | 0 participants | 11.77 |
| Gadobutrol-enhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 3 | DSCA | 1 participants | — |
| Gadobutrol-enhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 3 | CTA | 88 participants | 4.69 |
| Gadobutrol-enhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 3 | Nuclear medicine study | 0 participants | — |
| Gadobutrol-enhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 3 | Contrast-enhanced MRA | 12 participants | 6.99 |
| Unenhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 3 | Nuclear medicine study | 0 participants | — |
| Unenhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 3 | Contrast-enhanced MRA | 64 participants | 6.07 |
| Unenhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 3 | CTA | 316 participants | 3.76 |
| Unenhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 3 | Ultrasound | 0 participants | — |
| Unenhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 3 | DSCA | 0 participants | — |
| Unenhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 3 | Non-contrast MRA | 0 participants | 11.47 |
Secondary
Types of Additional Imaging Studies Recommended by the Clinical Investigator After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images
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
Population: Participants in FAS who were recommended for additional imaging studies.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Gadobutrol-enhanced MRA | Types of Additional Imaging Studies Recommended by the Clinical Investigator After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images | Non-contrast MRA | 1 participants | 11.77 |
| Gadobutrol-enhanced MRA | Types of Additional Imaging Studies Recommended by the Clinical Investigator After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images | Contrast-enhanced MRA | 0 participants | 6.99 |
| Gadobutrol-enhanced MRA | Types of Additional Imaging Studies Recommended by the Clinical Investigator After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images | CTA | 44 participants | 4.69 |
| Gadobutrol-enhanced MRA | Types of Additional Imaging Studies Recommended by the Clinical Investigator After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images | Ultrasound | 1 participants | — |
| Gadobutrol-enhanced MRA | Types of Additional Imaging Studies Recommended by the Clinical Investigator After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images | DSCA | 5 participants | — |
| Gadobutrol-enhanced MRA | Types of Additional Imaging Studies Recommended by the Clinical Investigator After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images | Nuclear medicine study | 0 participants | — |
| Unenhanced MRA | Types of Additional Imaging Studies Recommended by the Clinical Investigator After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images | DSCA | 4 participants | — |
| Unenhanced MRA | Types of Additional Imaging Studies Recommended by the Clinical Investigator After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images | Non-contrast MRA | 0 participants | 11.47 |
| Unenhanced MRA | Types of Additional Imaging Studies Recommended by the Clinical Investigator After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images | Ultrasound | 0 participants | — |
| Unenhanced MRA | Types of Additional Imaging Studies Recommended by the Clinical Investigator After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images | Contrast-enhanced MRA | 142 participants | 6.07 |
| Unenhanced MRA | Types of Additional Imaging Studies Recommended by the Clinical Investigator After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images | Nuclear medicine study | 0 participants | — |
| Unenhanced MRA | Types of Additional Imaging Studies Recommended by the Clinical Investigator After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images | CTA | 51 participants | 3.76 |
Secondary
Types of Artifacts on a Segment Basis by Blinded Reader 1
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
Population: Participants in FAS with artifacts presence.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol-enhanced MRA | Types of Artifacts on a Segment Basis by Blinded Reader 1 | Saturation artifact | 21.6 percentage of segments |
| Gadobutrol-enhanced MRA | Types of Artifacts on a Segment Basis by Blinded Reader 1 | Ringing artifact | 0.5 percentage of segments |
| Gadobutrol-enhanced MRA | Types of Artifacts on a Segment Basis by Blinded Reader 1 | Venous opacification | 9.8 percentage of segments |
| Gadobutrol-enhanced MRA | Types of Artifacts on a Segment Basis by Blinded Reader 1 | Bolus timing error | 4.3 percentage of segments |
| Gadobutrol-enhanced MRA | Types of Artifacts on a Segment Basis by Blinded Reader 1 | Susceptibility artifacts | 0.1 percentage of segments |
| Gadobutrol-enhanced MRA | Types of Artifacts on a Segment Basis by Blinded Reader 1 | Other | 9.3 percentage of segments |
| Gadobutrol-enhanced MRA | Types of Artifacts on a Segment Basis by Blinded Reader 1 | Motion artifact | 18.6 percentage of segments |
| Unenhanced MRA | Types of Artifacts on a Segment Basis by Blinded Reader 1 | Other | 48.0 percentage of segments |
| Unenhanced MRA | Types of Artifacts on a Segment Basis by Blinded Reader 1 | Motion artifact | 41.9 percentage of segments |
| Unenhanced MRA | Types of Artifacts on a Segment Basis by Blinded Reader 1 | Venous opacification | 0.8 percentage of segments |
| Unenhanced MRA | Types of Artifacts on a Segment Basis by Blinded Reader 1 | Saturation artifact | 38.2 percentage of segments |
| Unenhanced MRA | Types of Artifacts on a Segment Basis by Blinded Reader 1 | Susceptibility artifacts | 0.2 percentage of segments |
| Unenhanced MRA | Types of Artifacts on a Segment Basis by Blinded Reader 1 | Ringing artifact | 29.3 percentage of segments |
| Unenhanced MRA | Types of Artifacts on a Segment Basis by Blinded Reader 1 | Bolus timing error | 4.0 percentage of segments |
Secondary
Types of Artifacts on a Segment Basis by Blinded Reader 2
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
Population: Participants in FAS with artifacts presence.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol-enhanced MRA | Types of Artifacts on a Segment Basis by Blinded Reader 2 | Susceptibility artifacts | 0.8 percentage of segments |
| Gadobutrol-enhanced MRA | Types of Artifacts on a Segment Basis by Blinded Reader 2 | Motion artifact | 5.6 percentage of segments |
| Gadobutrol-enhanced MRA | Types of Artifacts on a Segment Basis by Blinded Reader 2 | Ringing artifact | 0.2 percentage of segments |
| Gadobutrol-enhanced MRA | Types of Artifacts on a Segment Basis by Blinded Reader 2 | Bolus timing error | 1.1 percentage of segments |
| Gadobutrol-enhanced MRA | Types of Artifacts on a Segment Basis by Blinded Reader 2 | Saturation artifact | 2.0 percentage of segments |
| Gadobutrol-enhanced MRA | Types of Artifacts on a Segment Basis by Blinded Reader 2 | Other | 0.5 percentage of segments |
| Gadobutrol-enhanced MRA | Types of Artifacts on a Segment Basis by Blinded Reader 2 | Venous opacification | 5.7 percentage of segments |
| Unenhanced MRA | Types of Artifacts on a Segment Basis by Blinded Reader 2 | Other | 0.3 percentage of segments |
| Unenhanced MRA | Types of Artifacts on a Segment Basis by Blinded Reader 2 | Motion artifact | 39.8 percentage of segments |
| Unenhanced MRA | Types of Artifacts on a Segment Basis by Blinded Reader 2 | Venous opacification | 0.3 percentage of segments |
| Unenhanced MRA | Types of Artifacts on a Segment Basis by Blinded Reader 2 | Saturation artifact | 24.5 percentage of segments |
| Unenhanced MRA | Types of Artifacts on a Segment Basis by Blinded Reader 2 | Susceptibility artifacts | 3.7 percentage of segments |
| Unenhanced MRA | Types of Artifacts on a Segment Basis by Blinded Reader 2 | Bolus timing error | 0.0 percentage of segments |
| Unenhanced MRA | Types of Artifacts on a Segment Basis by Blinded Reader 2 | Ringing artifact | 0.0 percentage of segments |
Secondary
Types of Artifacts on a Segment Basis by Blinded Reader 3
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
Population: Participants in FAS with artifacts presence.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol-enhanced MRA | Types of Artifacts on a Segment Basis by Blinded Reader 3 | Saturation artifact | 13.8 percentage of segments |
| Gadobutrol-enhanced MRA | Types of Artifacts on a Segment Basis by Blinded Reader 3 | Ringing artifact | 0.6 percentage of segments |
| Gadobutrol-enhanced MRA | Types of Artifacts on a Segment Basis by Blinded Reader 3 | Venous opacification | 1.7 percentage of segments |
| Gadobutrol-enhanced MRA | Types of Artifacts on a Segment Basis by Blinded Reader 3 | Bolus timing error | 1.6 percentage of segments |
| Gadobutrol-enhanced MRA | Types of Artifacts on a Segment Basis by Blinded Reader 3 | Susceptibility artifacts | 0.2 percentage of segments |
| Gadobutrol-enhanced MRA | Types of Artifacts on a Segment Basis by Blinded Reader 3 | Other | 0.4 percentage of segments |
| Gadobutrol-enhanced MRA | Types of Artifacts on a Segment Basis by Blinded Reader 3 | Motion artifact | 0.6 percentage of segments |
| Unenhanced MRA | Types of Artifacts on a Segment Basis by Blinded Reader 3 | Other | 0.1 percentage of segments |
| Unenhanced MRA | Types of Artifacts on a Segment Basis by Blinded Reader 3 | Motion artifact | 13.2 percentage of segments |
| Unenhanced MRA | Types of Artifacts on a Segment Basis by Blinded Reader 3 | Venous opacification | 0.1 percentage of segments |
| Unenhanced MRA | Types of Artifacts on a Segment Basis by Blinded Reader 3 | Saturation artifact | 39.4 percentage of segments |
| Unenhanced MRA | Types of Artifacts on a Segment Basis by Blinded Reader 3 | Susceptibility artifacts | 0.5 percentage of segments |
| Unenhanced MRA | Types of Artifacts on a Segment Basis by Blinded Reader 3 | Ringing artifact | 6.4 percentage of segments |
| Unenhanced MRA | Types of Artifacts on a Segment Basis by Blinded Reader 3 | Bolus timing error | 0.4 percentage of segments |
Secondary
Vessel Diameter (Millimeter [mm]) at the Normal Point and the Narrowest Point in Gadobutrol-Enhanced MRA, Unenhanced MRA and CTA Images
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gadobutrol-enhanced MRA | Vessel Diameter (Millimeter [mm]) at the Normal Point and the Narrowest Point in Gadobutrol-Enhanced MRA, Unenhanced MRA and CTA Images | Vessel DIA at normal point: BRs | 4.88 millimeter(s) (mm) | Standard Deviation 1.9 |
| Gadobutrol-enhanced MRA | Vessel Diameter (Millimeter [mm]) at the Normal Point and the Narrowest Point in Gadobutrol-Enhanced MRA, Unenhanced MRA and CTA Images | Vessel DIA at narrowest point: BRs | 3.23 millimeter(s) (mm) | Standard Deviation 1.54 |
| Gadobutrol-enhanced MRA | Vessel Diameter (Millimeter [mm]) at the Normal Point and the Narrowest Point in Gadobutrol-Enhanced MRA, Unenhanced MRA and CTA Images | Vessel DIA at normal point: CIs | 4.81 millimeter(s) (mm) | Standard Deviation 1.78 |
| Gadobutrol-enhanced MRA | Vessel Diameter (Millimeter [mm]) at the Normal Point and the Narrowest Point in Gadobutrol-Enhanced MRA, Unenhanced MRA and CTA Images | Vessel DIA at narrowest point: CIs | 2.42 millimeter(s) (mm) | Standard Deviation 1.37 |
| Unenhanced MRA | Vessel Diameter (Millimeter [mm]) at the Normal Point and the Narrowest Point in Gadobutrol-Enhanced MRA, Unenhanced MRA and CTA Images | Vessel DIA at narrowest point: CIs | 2.31 millimeter(s) (mm) | Standard Deviation 1.21 |
| Unenhanced MRA | Vessel Diameter (Millimeter [mm]) at the Normal Point and the Narrowest Point in Gadobutrol-Enhanced MRA, Unenhanced MRA and CTA Images | Vessel DIA at normal point: BRs | 4.33 millimeter(s) (mm) | Standard Deviation 1.53 |
| Unenhanced MRA | Vessel Diameter (Millimeter [mm]) at the Normal Point and the Narrowest Point in Gadobutrol-Enhanced MRA, Unenhanced MRA and CTA Images | Vessel DIA at normal point: CIs | 4.54 millimeter(s) (mm) | Standard Deviation 1.58 |
| Unenhanced MRA | Vessel Diameter (Millimeter [mm]) at the Normal Point and the Narrowest Point in Gadobutrol-Enhanced MRA, Unenhanced MRA and CTA Images | Vessel DIA at narrowest point: BRs | 2.66 millimeter(s) (mm) | Standard Deviation 1.34 |
| Computed Tomographic Angiography | Vessel Diameter (Millimeter [mm]) at the Normal Point and the Narrowest Point in Gadobutrol-Enhanced MRA, Unenhanced MRA and CTA Images | Vessel DIA at narrowest point: CIs | 2.68 millimeter(s) (mm) | Standard Deviation 1.62 |
| Computed Tomographic Angiography | Vessel Diameter (Millimeter [mm]) at the Normal Point and the Narrowest Point in Gadobutrol-Enhanced MRA, Unenhanced MRA and CTA Images | Vessel DIA at narrowest point: BRs | 3.00 millimeter(s) (mm) | Standard Deviation 1.5 |
| Computed Tomographic Angiography | Vessel Diameter (Millimeter [mm]) at the Normal Point and the Narrowest Point in Gadobutrol-Enhanced MRA, Unenhanced MRA and CTA Images | Vessel DIA at normal point: CIs | 5.17 millimeter(s) (mm) | Standard Deviation 2.02 |
| Computed Tomographic Angiography | Vessel Diameter (Millimeter [mm]) at the Normal Point and the Narrowest Point in Gadobutrol-Enhanced MRA, Unenhanced MRA and CTA Images | Vessel DIA at normal point: BRs | 4.98 millimeter(s) (mm) | Standard Deviation 2.08 |
Comparison: CTA Minus Unenhanced MRA for blinded Reader on vessel DIA at normal pointMean Difference
Comparison: CTA minus Gadobutrol-Enhanced MRA for blinded reader on vessel DIA at normal pointMean Difference
Comparison: CTA minus Unenhanced MRA for blinded reader on vessel DIA at narrowest pointMean Difference
Comparison: CTA minus Gadobutrol-Enhanced MRA for blinded reader on vessel DIA at narrowest pointMean Difference
Comparison: CTA minus Unenhanced MRA for clinical investigators on vessel DIA at normal pointMean Difference
Comparison: CTA minus Gadobutrol-enhanced MRA for clinical investigators on vessel DIA at normal pointMean Difference
Comparison: CTA minus Unenhanced MRA for clinical investigators on vessel DIA at narrowest pointMean Difference
Comparison: CTA minus Gadobutrol-enhanced MRA for clinical investigators on vessel DIA at narrowest pointMean Difference