Renal Artery Obstruction
Conditions
Keywords
magnetic resonance angiography (MRA) of the renal arteries
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
NON_RANDOMIZED
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 * Known or suspected renal artery disease based on any of the following: * Referred for evaluation of the renal arteries for clinically significant stenosis * Follow-up for a metallic stent in a renal artery * Prior imaging study (CTA) showing ≥ 50% renal artery stenosis (within 60 days prior to consent) * Willingness to undergo the routine Contrast Enhanced Magnetic Resonance Angiography (CE MRA) examinations 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 prior to administration of study drug. * Written informed consent (IC), including information about the provisions of the Health Insurance Portability and Accountability Act (HIPAA) as applicable.
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 enrolment 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 Nefrogenic 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
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 (reader 1, 2 and 3) and majority readers (the outcome determined by at least two of the blinded readers). The segments were predefined to standardize the blinded reader evaluations. A segment was assessable if it was visualized along its entire length and if any region of stenosis, was measured reliably. There were 6 segments assessed per participant (3 segments in the right renal artery and 3 segments in the left renal artery) and up to 9 segments in participants with renal transplant. |
| 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 50 to 99 percent (%) stenosis of a segment, but not occluded as assessed by the SoR. For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. |
| 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 (stenosis) was defined as 50 to 99 percent (%) stenosis of a segment, but not occluded as assessed by the SoR. For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. Specificity = percentage of participants for which the imaging modalities (unenhanced or gadobutrol-enhanced) in the detection and exclusion of clinically significant stenosis. |
| Minimum Gadobutrol Performance for Sensitivity: Sensitivity More Than (>) 50% | Images were taken pre-injection and post-injection | Clinically significant disease was defined as \>50% stenosis of a segment, but not occluded as assessed by the SoR. 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 (stenosis) was defined as \>50% stenosis of a segment, but not occluded as assessed by the SoR. 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 |
|---|---|---|
| Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA 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 Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA 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 Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA 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). |
| The Percentage of Accessory (Non-dominant) Renal Artery Presence Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Images were taken pre-injection and post-injection | An accessory renal artery was defined as an additional, non-dominant, renal artery typically emanating from the aorta and anastomosing distal to the proximal third, segment of that renal artery. It was recorded only as present or absent on the right and left, regardless of how many accessory renal arteries were present. |
| The Presence of Any Aneurysmal Dilatation in Each Segment (Proximal, Mid- and Distal) in the Right and the Left Renal Arteries Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Images were taken pre-injection and post-injection | Any focal dilatation (aneurysmal dilatation) of a segment was recorded. The diameter at the widest point was measured with the electronic calipers if a dilatation was present in any segment. The number of participants with an aneurysmal dilatation in each segment (proximal, mid- and distal) in the right and the left renal arteries assessed by gadobutrol-enhanced MRA and unenhanced MRA were reported. |
| The Percentage of Participants With Diagnosis of Fibromuscular Dysplasia and Arteriosclerosis Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Images were taken pre-injection and post-injection | Any focal dilatation (aneurysmal dilatation) of a segment was recorded. The diameter at the widest point was measured with the electronic calipers if a dilatation was present in any segment. The number of participants with an aneurysmal dilatation in each segment (proximal, mid- and distal) in the right and the left renal arteries assessed by gadobutrol-enhanced MRA and unenhanced MRA were reported. |
| Length of the Right and Left Renal Arteries Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA - Blinded Reader | Images were taken pre-injection and post-injection | The length of the left and right renal arteries were measured from the origin at the aorta to the bifurcation into the upper and lower pole arteries or the most distal point of the renal artery which could be visualized. This distal margin was the point where the diameter was still assessable. If there were more than 2 distal branches then the first large branch that was the dominant supply to a renal pole was used as the distal point. |
| The Percentage of Participants With Additional Imaging Studies Recommended by the Blinded Readers and the Clinical Investigator After Evaluation of the Gadobutrol-Enhanced and Unenhanced 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 had recommended an additional imaging study for each participant, and the data were recorded. |
| Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced 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 Gadobutrol-Enhanced and Unenhanced 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 Gadobutrol-Enhanced and Unenhanced 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. |
| 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; 4=Very confident. |
| Length of the Right and Left Renal Arteries Assessed by Computed Tomographic Angiography (CTA) - Blinded Reader | Images were taken pre-injection and post-injection | The length of the left and right renal arteries were measured from the origin at the aorta to the bifurcation into the upper and lower pole arteries or the most distal point of the renal artery which could be visualized. This distal margin was the point where the diameter was still assessable. If there were more than 2 distal branches then the first large branch that was the dominant supply to a renal pole was used as the distal point. |
| 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 the ease of expression, the following abbreviations will be used: Diameter (DIA), Blinded Reader (BR). |
| The Percentage of Location of Stenosis >= 50% (Within and Beyond 5 Millimeter From the Aorta) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Images were taken pre-injection and post-injection | Location within the right and left proximal segment was based on the point of greatest stenosis and was recorded for stenosis \>=50% as: - Within 5 mm of the aorta (or occlusion proximal to the origin of the segment); - Beyond 5 mm from the aorta. |
| 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. |
Countries
Argentina, Austria, Brazil, Colombia, Czechia, France, Germany, Poland, South Korea, Switzerland, Taiwan, Turkey (Türkiye), United States
Participant flow
Recruitment details
The study was conducted at 55 study centers in 13 countries, between 16 May 2011 (first participant first visit) and 06 July 2012 (last participant last visit).
Pre-assignment details
A total of 338 participants were screened, of which 317 were enrolled and 315 received the study drug. The 23 participants who did not receive the study drug included 9 screen failures and 12 premature discontinuations (10 participants withdrew consent and 2 participants for other reasons) and 2 participants never received the study drug.
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 mmol/kg body weight (bw) by single intravenous (i.v.) bolus injection. During the course of the study, non-contrast magnetic resonance angiography (MRA) images were obtained before the administration of gadobutrol, and gadobutrol-enhanced MRA images were obtained after injection. | 315 |
| Total | 315 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Gadobutrol (Gadavist, BAY 86-4875) |
|---|---|
| Age, Continuous | 54.9 years STANDARD_DEVIATION 16.9 |
| Age, Customized 45 - 64 years | 111 participants |
| Age, Customized < 45 years | 92 participants |
| Age, Customized >= 65 years | 112 participants |
| Baseline Weight | 77.5 kilogram(s) STANDARD_DEVIATION 16.9 |
| Sex: Female, Male Female | 145 Participants |
| Sex: Female, Male Male | 170 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 14 / 315 |
| serious Total, serious adverse events | 0 / 315 |
Outcome results
Primary
Minimum Gadobutrol Performance for Sensitivity: Sensitivity More Than (>) 50%
Clinically significant disease was defined as \>50% stenosis of a segment, but not occluded as assessed by the SoR. 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 More Than (>) 50% | Majority reader (n=84/119) | 54.6 percentage of sensitivity |
| Gadobutrol-enhanced MRA | Minimum Gadobutrol Performance for Sensitivity: Sensitivity More Than (>) 50% | Blinded reader 1 (n=91/128) | 51.6 percentage of sensitivity |
| Gadobutrol-enhanced MRA | Minimum Gadobutrol Performance for Sensitivity: Sensitivity More Than (>) 50% | Blinded reader 2 (n=82/114) | 54.4 percentage of sensitivity |
| Gadobutrol-enhanced MRA | Minimum Gadobutrol Performance for Sensitivity: Sensitivity More Than (>) 50% | Blinded reader 3 (n=83/118) | 53.4 percentage of sensitivity |
| Gadobutrol-enhanced MRA | Minimum Gadobutrol Performance for Sensitivity: Sensitivity More Than (>) 50% | Clinical investigators (n=108/129) | 71.3 percentage of sensitivity |
Comparison: Majority readerOne sided 95% confidence interval
Comparison: Blinded Reader 1One sided 95% confidence interval
Comparison: Blinded Reader 2One sided 95% confidence interval
Comparison: Blinded Reader 3One sided 95% confidence interval
Comparison: Clinical investigatorOne sided 95% confidence interval
Primary
Minimum Gadobutrol Performance for Specificity: Specificity > 50%
Clinically significant disease (stenosis) was defined as \>50% stenosis of a segment, but not occluded as assessed by the SoR. 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=291/1555) | 95.9 percentage of specificity |
| Gadobutrol-enhanced MRA | Minimum Gadobutrol Performance for Specificity: Specificity > 50% | Blinded reader 1 (n=292/1585) | 95.0 percentage of specificity |
| Gadobutrol-enhanced MRA | Minimum Gadobutrol Performance for Specificity: Specificity > 50% | Blinded reader 2 (n=291/1554) | 96.2 percentage of specificity |
| Gadobutrol-enhanced MRA | Minimum Gadobutrol Performance for Specificity: Specificity > 50% | Blinded reader 3 (n=290/1544) | 95.8 percentage of specificity |
| Gadobutrol-enhanced MRA | Minimum Gadobutrol Performance for Specificity: Specificity > 50% | Clinical investigators (n=289/1535) | 98.4 percentage of specificity |
Comparison: Majority readerOne sided 95% confidence interval
Comparison: Blinded Reader 1One sided 95% confidence interval
Comparison: Blinded Reader 2One sided 95% confidence interval
Comparison: Blinded Reader 3One sided 95% confidence interval
Comparison: Clinical investigatorOne sided 95% 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 (reader 1, 2 and 3) and majority readers (the outcome determined by at least two of the blinded readers). The segments were predefined to standardize the blinded reader evaluations. A segment was assessable if it was visualized along its entire length and if any region of stenosis, was measured reliably. There were 6 segments assessed per participant (3 segments in the right renal artery and 3 segments in the left renal artery) and up to 9 segments in participants with renal transplant.
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 for both groups.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol-enhanced MRA | Percentage of Assessable Vascular Segments Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Blinded reader 1 (n=292/1746) | 98.1 Percentage of segments |
| Gadobutrol-enhanced MRA | Percentage of Assessable Vascular Segments Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Blinded reader 3 (n=292/1734) | 95.5 Percentage of segments |
| Gadobutrol-enhanced MRA | Percentage of Assessable Vascular Segments Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Blinded reader 2 (n=292/1752) | 95.5 Percentage of segments |
| Gadobutrol-enhanced MRA | Percentage of Assessable Vascular Segments Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Clinical investigators (n=292/1764) | 94.4 Percentage of segments |
| Gadobutrol-enhanced MRA | Percentage of Assessable Vascular Segments Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Majority reader (n=292/1752) | 95.9 Percentage of segments |
| Unenhanced MRA | Percentage of Assessable Vascular Segments Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Clinical investigators (n=292/1764) | 68.9 Percentage of segments |
| Unenhanced MRA | Percentage of Assessable Vascular Segments Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Majority reader (n=292/1752) | 77.6 Percentage of segments |
| Unenhanced MRA | Percentage of Assessable Vascular Segments Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Blinded reader 1 (n=292/1746) | 81.7 Percentage of segments |
| Unenhanced MRA | Percentage of Assessable Vascular Segments Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Blinded reader 2 (n=292/1752) | 71.5 Percentage of segments |
| Unenhanced MRA | Percentage of Assessable Vascular Segments Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Blinded reader 3 (n=292/1734) | 78.1 Percentage of segments |
Comparison: Majority reader; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.p-value: <0McNemar
Comparison: Blinded reader 1; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.p-value: <0McNemar
Comparison: Blinded reader 2; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.p-value: <0McNemar
Comparison: Blinded reader 3; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.p-value: <0McNemar
Comparison: Clinical investigator; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.p-value: <0McNemar
Primary
Sensitivity for Detection of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA
Clinically significant disease was defined as 50 to 99 percent (%) stenosis of a segment, but not occluded as assessed by the SoR. For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease.
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 | Sensitivity for Detection of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Blinded reader 1 (n=93/133) | 51.9 percentage of sensitivity |
| Gadobutrol-enhanced MRA | Sensitivity for Detection of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Blinded reader 3 (n=93/133) | 52.6 percentage of sensitivity |
| Gadobutrol-enhanced MRA | Sensitivity for Detection of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Blinded reader 2 (n=93/133) | 54.1 percentage of sensitivity |
| Gadobutrol-enhanced MRA | Sensitivity for Detection of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Clinical investigators (n=113/140) | 69.3 percentage of sensitivity |
| Gadobutrol-enhanced MRA | Sensitivity for Detection of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Majority reader | 53.4 percentage of sensitivity |
| Unenhanced MRA | Sensitivity for Detection of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Clinical investigators (n=113/140) | 50.0 percentage of sensitivity |
| Unenhanced MRA | Sensitivity for Detection of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Majority reader | 46.6 percentage of sensitivity |
| Unenhanced MRA | Sensitivity for Detection of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Blinded reader 1 (n=93/133) | 51.1 percentage of sensitivity |
| Unenhanced MRA | Sensitivity for Detection of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Blinded reader 2 (n=93/133) | 39.1 percentage of sensitivity |
| Unenhanced MRA | Sensitivity for Detection of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Blinded reader 3 (n=93/133) | 50.4 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 (stenosis) was defined as 50 to 99 percent (%) stenosis of a segment, but not occluded as assessed by the SoR. For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. Specificity = percentage of participants for which the imaging modalities (unenhanced or gadobutrol-enhanced) in the detection and exclusion of clinically significant stenosis.
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 | Specificity for Exclusion of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Blinded reader 1 (n=292/1605) | 94.4 percentage of specificity |
| Gadobutrol-enhanced MRA | Specificity for Exclusion of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Blinded reader 3 (n=292/1605) | 94.0 percentage of specificity |
| Gadobutrol-enhanced MRA | Specificity for Exclusion of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Blinded reader 2 (n=292/1605) | 94.8 percentage of specificity |
| Gadobutrol-enhanced MRA | Specificity for Exclusion of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Clinical investigators (n=292/1598) | 96.5 percentage of specificity |
| Gadobutrol-enhanced MRA | Specificity for Exclusion of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Majority reader (n=292/1605) | 94.8 percentage of specificity |
| Unenhanced MRA | Specificity for Exclusion of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Clinical investigators (n=292/1598) | 83.5 percentage of specificity |
| Unenhanced MRA | Specificity for Exclusion of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Majority reader (n=292/1605) | 85.7 percentage of specificity |
| Unenhanced MRA | Specificity for Exclusion of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Blinded reader 1 (n=292/1605) | 83.1 percentage of specificity |
| Unenhanced MRA | Specificity for Exclusion of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Blinded reader 2 (n=292/1605) | 85.0 percentage of specificity |
| Unenhanced MRA | Specificity for Exclusion of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Blinded reader 3 (n=292/1605) | 80.7 percentage of specificity |
Comparison: Blinded reader 1; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.The cluster-adjusted two-sided 95% CI
Comparison: Majority reader; 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; 4=Very confident.
Time frame: Images were taken pre-injection and post-injection
Population: FAS; In the below table, n signifies the number of segments that were evaluable in specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gadobutrol-enhanced MRA | Diagnostic Confidence by the Blinded Readers Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Blinded reader 1(n=1745; 1728) | 3.0 Units on scale | Standard Deviation 0.8 |
| Gadobutrol-enhanced MRA | Diagnostic Confidence by the Blinded Readers Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Blinded reader 2 (n=1745; 1729) | 3.5 Units on scale | Standard Deviation 0.8 |
| Gadobutrol-enhanced MRA | Diagnostic Confidence by the Blinded Readers Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Blinded reader 3 (n=1749; 1737) | 3.5 Units on scale | Standard Deviation 0.8 |
| Unenhanced MRA | Diagnostic Confidence by the Blinded Readers Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Blinded reader 1(n=1745; 1728) | 1.9 Units on scale | Standard Deviation 0.7 |
| Unenhanced MRA | Diagnostic Confidence by the Blinded Readers Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Blinded reader 2 (n=1745; 1729) | 2.1 Units on scale | Standard Deviation 1 |
| Unenhanced MRA | Diagnostic Confidence by the Blinded Readers Using Gadobutrol-Enhanced MRA and Unenhanced MRA | Blinded reader 3 (n=1749; 1737) | 2.2 Units on scale | Standard Deviation 0.9 |
Secondary
Length of the Right and Left Renal Arteries Assessed by Computed Tomographic Angiography (CTA) - Blinded Reader
The length of the left and right renal arteries were measured from the origin at the aorta to the bifurcation into the upper and lower pole arteries or the most distal point of the renal artery which could be visualized. This distal margin was the point where the diameter was still assessable. If there were more than 2 distal branches then the first large branch that was the dominant supply to a renal pole was used as the distal point.
Time frame: Images were taken pre-injection and post-injection
Population: Evaluable participants in FAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gadobutrol-enhanced MRA | Length of the Right and Left Renal Arteries Assessed by Computed Tomographic Angiography (CTA) - Blinded Reader | Left renal artery- CTA Blind reader 4 | 36.59 millimeter(s) (mm) | Standard Deviation 12.14 |
| Gadobutrol-enhanced MRA | Length of the Right and Left Renal Arteries Assessed by Computed Tomographic Angiography (CTA) - Blinded Reader | Right renal artery - CTA Blind reader 4 | 48.44 millimeter(s) (mm) | Standard Deviation 14.51 |
| Gadobutrol-enhanced MRA | Length of the Right and Left Renal Arteries Assessed by Computed Tomographic Angiography (CTA) - Blinded Reader | Left renal artery- CTA Blind reader 5 | 36.59 millimeter(s) (mm) | Standard Deviation 12.14 |
| Gadobutrol-enhanced MRA | Length of the Right and Left Renal Arteries Assessed by Computed Tomographic Angiography (CTA) - Blinded Reader | Right renal artery - CTA Blind reader 5 | 48.44 millimeter(s) (mm) | Standard Deviation 14.5 |
| Gadobutrol-enhanced MRA | Length of the Right and Left Renal Arteries Assessed by Computed Tomographic Angiography (CTA) - Blinded Reader | Left renal artery- CTA Blind reader 6 | 36.59 millimeter(s) (mm) | Standard Deviation 12.14 |
| Gadobutrol-enhanced MRA | Length of the Right and Left Renal Arteries Assessed by Computed Tomographic Angiography (CTA) - Blinded Reader | Right renal artery - CTA Blind reader 6 | 48.45 millimeter(s) (mm) | Standard Deviation 14.5 |
Secondary
Length of the Right and Left Renal Arteries Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA - Blinded Reader
The length of the left and right renal arteries were measured from the origin at the aorta to the bifurcation into the upper and lower pole arteries or the most distal point of the renal artery which could be visualized. This distal margin was the point where the diameter was still assessable. If there were more than 2 distal branches then the first large branch that was the dominant supply to a renal pole was used as the distal point.
Time frame: Images were taken pre-injection and post-injection
Population: Evaluable participants in FAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gadobutrol-enhanced MRA | Length of the Right and Left Renal Arteries Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA - Blinded Reader | Left renal artery- Blind reader 1 | 35.07 millimeter(s) (mm) | Standard Deviation 11.76 |
| Gadobutrol-enhanced MRA | Length of the Right and Left Renal Arteries Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA - Blinded Reader | Right renal artery - Blind reader 1 | 46.23 millimeter(s) (mm) | Standard Deviation 14.01 |
| Gadobutrol-enhanced MRA | Length of the Right and Left Renal Arteries Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA - Blinded Reader | Left renal artery- Blind reader 2 | 35.07 millimeter(s) (mm) | Standard Deviation 11.76 |
| Gadobutrol-enhanced MRA | Length of the Right and Left Renal Arteries Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA - Blinded Reader | Right renal artery - Blind reader 2 | 46.27 millimeter(s) (mm) | Standard Deviation 14.01 |
| Gadobutrol-enhanced MRA | Length of the Right and Left Renal Arteries Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA - Blinded Reader | Left renal artery- Blind reader 3 | 35.07 millimeter(s) (mm) | Standard Deviation 11.76 |
| Gadobutrol-enhanced MRA | Length of the Right and Left Renal Arteries Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA - Blinded Reader | Right renal artery - Blind reader 3 | 46.23 millimeter(s) (mm) | Standard Deviation 14 |
| Unenhanced MRA | Length of the Right and Left Renal Arteries Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA - Blinded Reader | Left renal artery- Blind reader 3 | 32.64 millimeter(s) (mm) | Standard Deviation 12.74 |
| Unenhanced MRA | Length of the Right and Left Renal Arteries Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA - Blinded Reader | Left renal artery- Blind reader 1 | 32.25 millimeter(s) (mm) | Standard Deviation 11.32 |
| Unenhanced MRA | Length of the Right and Left Renal Arteries Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA - Blinded Reader | Right renal artery - Blind reader 2 | 42.95 millimeter(s) (mm) | Standard Deviation 14.42 |
| Unenhanced MRA | Length of the Right and Left Renal Arteries Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA - Blinded Reader | Right renal artery - Blind reader 1 | 43.05 millimeter(s) (mm) | Standard Deviation 14.34 |
| Unenhanced MRA | Length of the Right and Left Renal Arteries Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA - Blinded Reader | Right renal artery - Blind reader 3 | 43.05 millimeter(s) (mm) | Standard Deviation 14.34 |
| Unenhanced MRA | Length of the Right and Left Renal Arteries Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA - Blinded Reader | Left renal artery- Blind reader 2 | 32.15 millimeter(s) (mm) | Standard Deviation 11.35 |
Secondary
The Percentage of Accessory (Non-dominant) Renal Artery Presence Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA
An accessory renal artery was defined as an additional, non-dominant, renal artery typically emanating from the aorta and anastomosing distal to the proximal third, segment of that renal artery. It was recorded only as present or absent on the right and left, regardless of how many accessory renal arteries were present.
Time frame: Images were taken pre-injection and post-injection
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol-enhanced MRA | The Percentage of Accessory (Non-dominant) Renal Artery Presence Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Left side: Reader 1 | 7.2 percentage of accessory |
| Gadobutrol-enhanced MRA | The Percentage of Accessory (Non-dominant) Renal Artery Presence Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Right side: Reader 1 | 9.2 percentage of accessory |
| Gadobutrol-enhanced MRA | The Percentage of Accessory (Non-dominant) Renal Artery Presence Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Left side: Reader 2 | 15.4 percentage of accessory |
| Gadobutrol-enhanced MRA | The Percentage of Accessory (Non-dominant) Renal Artery Presence Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Right side: Reader 2 | 17.8 percentage of accessory |
| Gadobutrol-enhanced MRA | The Percentage of Accessory (Non-dominant) Renal Artery Presence Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Left side: Reader 3 | 13.4 percentage of accessory |
| Gadobutrol-enhanced MRA | The Percentage of Accessory (Non-dominant) Renal Artery Presence Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Right side: Reader 3 | 16.4 percentage of accessory |
| Gadobutrol-enhanced MRA | The Percentage of Accessory (Non-dominant) Renal Artery Presence Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Left side: Clinical investigators | 18.2 percentage of accessory |
| Gadobutrol-enhanced MRA | The Percentage of Accessory (Non-dominant) Renal Artery Presence Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Right side: Clinical investigators | 19.2 percentage of accessory |
| Unenhanced MRA | The Percentage of Accessory (Non-dominant) Renal Artery Presence Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Right side: Clinical investigators | 12.7 percentage of accessory |
| Unenhanced MRA | The Percentage of Accessory (Non-dominant) Renal Artery Presence Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Left side: Reader 1 | 0.7 percentage of accessory |
| Unenhanced MRA | The Percentage of Accessory (Non-dominant) Renal Artery Presence Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Left side: Reader 3 | 5.8 percentage of accessory |
| Unenhanced MRA | The Percentage of Accessory (Non-dominant) Renal Artery Presence Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Right side: Reader 1 | 1.4 percentage of accessory |
| Unenhanced MRA | The Percentage of Accessory (Non-dominant) Renal Artery Presence Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Left side: Clinical investigators | 11.6 percentage of accessory |
| Unenhanced MRA | The Percentage of Accessory (Non-dominant) Renal Artery Presence Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Left side: Reader 2 | 2.7 percentage of accessory |
| Unenhanced MRA | The Percentage of Accessory (Non-dominant) Renal Artery Presence Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Right side: Reader 3 | 4.5 percentage of accessory |
| Unenhanced MRA | The Percentage of Accessory (Non-dominant) Renal Artery Presence Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Right side: Reader 2 | 3.1 percentage of accessory |
Secondary
The Percentage of Location of Stenosis >= 50% (Within and Beyond 5 Millimeter From the Aorta) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA
Location within the right and left proximal segment was based on the point of greatest stenosis and was recorded for stenosis \>=50% as: - Within 5 mm of the aorta (or occlusion proximal to the origin of the segment); - Beyond 5 mm from the aorta.
Time frame: Images were taken pre-injection and post-injection
Population: Participants in FAS that were evaluable; in below table, n signifies the number of segments that were evaluable in specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol-enhanced MRA | The Percentage of Location of Stenosis >= 50% (Within and Beyond 5 Millimeter From the Aorta) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Within 5 mm of the aorta BR 1 (n=110; 105) | 26.4 Percentage of location |
| Gadobutrol-enhanced MRA | The Percentage of Location of Stenosis >= 50% (Within and Beyond 5 Millimeter From the Aorta) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Within 5 mm of the aorta BR 2(n=83; 39) | 73.5 Percentage of location |
| Gadobutrol-enhanced MRA | The Percentage of Location of Stenosis >= 50% (Within and Beyond 5 Millimeter From the Aorta) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Within 5 mm of the aorta BR 3 (n=83; 87) | 25.3 Percentage of location |
| Gadobutrol-enhanced MRA | The Percentage of Location of Stenosis >= 50% (Within and Beyond 5 Millimeter From the Aorta) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Beyond 5 mm from the aorta BR 1 (n=110; 105) | 73.6 Percentage of location |
| Gadobutrol-enhanced MRA | The Percentage of Location of Stenosis >= 50% (Within and Beyond 5 Millimeter From the Aorta) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Beyond 5 mm from the aorta BR 2 (n=83; 39) | 26.5 Percentage of location |
| Gadobutrol-enhanced MRA | The Percentage of Location of Stenosis >= 50% (Within and Beyond 5 Millimeter From the Aorta) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Beyond 5 mm from the aorta BR 3 (n=83; 87) | 74.7 Percentage of location |
| Unenhanced MRA | The Percentage of Location of Stenosis >= 50% (Within and Beyond 5 Millimeter From the Aorta) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Beyond 5 mm from the aorta BR 2 (n=83; 39) | 28.2 Percentage of location |
| Unenhanced MRA | The Percentage of Location of Stenosis >= 50% (Within and Beyond 5 Millimeter From the Aorta) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Within 5 mm of the aorta BR 1 (n=110; 105) | 22.9 Percentage of location |
| Unenhanced MRA | The Percentage of Location of Stenosis >= 50% (Within and Beyond 5 Millimeter From the Aorta) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Beyond 5 mm from the aorta BR 1 (n=110; 105) | 77.1 Percentage of location |
| Unenhanced MRA | The Percentage of Location of Stenosis >= 50% (Within and Beyond 5 Millimeter From the Aorta) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Within 5 mm of the aorta BR 2(n=83; 39) | 71.8 Percentage of location |
| Unenhanced MRA | The Percentage of Location of Stenosis >= 50% (Within and Beyond 5 Millimeter From the Aorta) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Beyond 5 mm from the aorta BR 3 (n=83; 87) | 78.2 Percentage of location |
| Unenhanced MRA | The Percentage of Location of Stenosis >= 50% (Within and Beyond 5 Millimeter From the Aorta) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Within 5 mm of the aorta BR 3 (n=83; 87) | 21.8 Percentage of location |
Secondary
The Percentage of Participants With Additional Imaging Studies Recommended by the Blinded Readers and the Clinical Investigator After Evaluation of the Gadobutrol-Enhanced and Unenhanced 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 had recommended an additional imaging study for each participant, and the data were 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 Gadobutrol-Enhanced and Unenhanced MRA Images | Blinded reader 1 | 41.4 percentage of participants | 0.8 |
| Gadobutrol-enhanced MRA | The Percentage of Participants With Additional Imaging Studies Recommended by the Blinded Readers and the Clinical Investigator After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images | Blinded reader 2 | 14.0 percentage of participants | 0.8 |
| Gadobutrol-enhanced MRA | The Percentage of Participants With Additional Imaging Studies Recommended by the Blinded Readers and the Clinical Investigator After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images | Blinded reader 3 | 8.6 percentage of participants | 0.8 |
| Gadobutrol-enhanced MRA | The Percentage of Participants With Additional Imaging Studies Recommended by the Blinded Readers and the Clinical Investigator After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images | Clinical investigators | 18.8 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 Gadobutrol-Enhanced and Unenhanced MRA Images | Clinical investigators | 43.5 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 Gadobutrol-Enhanced and Unenhanced MRA Images | Blinded reader 1 | 96.6 percentage of participants | 0.7 |
| Unenhanced MRA | The Percentage of Participants With Additional Imaging Studies Recommended by the Blinded Readers and the Clinical Investigator After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images | Blinded reader 3 | 44.9 percentage of participants | 0.9 |
| Unenhanced MRA | The Percentage of Participants With Additional Imaging Studies Recommended by the Blinded Readers and the Clinical Investigator After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images | Blinded reader 2 | 77.1 percentage of participants | 1 |
Secondary
The Percentage of Participants With Diagnosis of Fibromuscular Dysplasia and Arteriosclerosis Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA
Any focal dilatation (aneurysmal dilatation) of a segment was recorded. The diameter at the widest point was measured with the electronic calipers if a dilatation was present in any segment. The number of participants with an aneurysmal dilatation in each segment (proximal, mid- and distal) in the right and the left renal arteries assessed by gadobutrol-enhanced MRA and unenhanced MRA were reported.
Time frame: Images were taken pre-injection and post-injection
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol-enhanced MRA | The Percentage of Participants With Diagnosis of Fibromuscular Dysplasia and Arteriosclerosis Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Fibromuscular dysplasia : reader 1 | 2.7 percentage of participants |
| Gadobutrol-enhanced MRA | The Percentage of Participants With Diagnosis of Fibromuscular Dysplasia and Arteriosclerosis Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Arteriosclerotic : reader 1 | 16.4 percentage of participants |
| Gadobutrol-enhanced MRA | The Percentage of Participants With Diagnosis of Fibromuscular Dysplasia and Arteriosclerosis Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Fibromuscular dysplasia : reader 2 | 4.1 percentage of participants |
| Gadobutrol-enhanced MRA | The Percentage of Participants With Diagnosis of Fibromuscular Dysplasia and Arteriosclerosis Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Arteriosclerotic : reader 2 | 38.4 percentage of participants |
| Gadobutrol-enhanced MRA | The Percentage of Participants With Diagnosis of Fibromuscular Dysplasia and Arteriosclerosis Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Fibromuscular dysplasia : reader 3 | 6.2 percentage of participants |
| Gadobutrol-enhanced MRA | The Percentage of Participants With Diagnosis of Fibromuscular Dysplasia and Arteriosclerosis Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Arteriosclerotic : reader 3 | 41.1 percentage of participants |
| Unenhanced MRA | The Percentage of Participants With Diagnosis of Fibromuscular Dysplasia and Arteriosclerosis Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Fibromuscular dysplasia : reader 3 | 0.7 percentage of participants |
| Unenhanced MRA | The Percentage of Participants With Diagnosis of Fibromuscular Dysplasia and Arteriosclerosis Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Fibromuscular dysplasia : reader 1 | 0.7 percentage of participants |
| Unenhanced MRA | The Percentage of Participants With Diagnosis of Fibromuscular Dysplasia and Arteriosclerosis Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Arteriosclerotic : reader 2 | 18.8 percentage of participants |
| Unenhanced MRA | The Percentage of Participants With Diagnosis of Fibromuscular Dysplasia and Arteriosclerosis Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Arteriosclerotic : reader 1 | 12.0 percentage of participants |
| Unenhanced MRA | The Percentage of Participants With Diagnosis of Fibromuscular Dysplasia and Arteriosclerosis Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Arteriosclerotic : reader 3 | 54.5 percentage of participants |
| Unenhanced MRA | The Percentage of Participants With Diagnosis of Fibromuscular Dysplasia and Arteriosclerosis Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Fibromuscular dysplasia : reader 2 | 0.0 percentage of participants |
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 3 | 41.5 percentage of segments |
| Gadobutrol-enhanced MRA | The Percentage of Segments With Artifacts Presence | Blinded Reader 1 | 24.7 percentage of segments |
| Gadobutrol-enhanced MRA | The Percentage of Segments With Artifacts Presence | Blinded Reader 2 | 22.1 percentage of segments |
| Unenhanced MRA | The Percentage of Segments With Artifacts Presence | Blinded Reader 2 | 80.4 percentage of segments |
| Unenhanced MRA | The Percentage of Segments With Artifacts Presence | Blinded Reader 1 | 92.3 percentage of segments |
| Unenhanced MRA | The Percentage of Segments With Artifacts Presence | Blinded Reader 3 | 97.4 percentage of segments |
Secondary
The Presence of Any Aneurysmal Dilatation in Each Segment (Proximal, Mid- and Distal) in the Right and the Left Renal Arteries Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA
Any focal dilatation (aneurysmal dilatation) of a segment was recorded. The diameter at the widest point was measured with the electronic calipers if a dilatation was present in any segment. The number of participants with an aneurysmal dilatation in each segment (proximal, mid- and distal) in the right and the left renal arteries assessed by gadobutrol-enhanced MRA and unenhanced MRA were reported.
Time frame: Images were taken pre-injection and post-injection
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol-enhanced MRA | The Presence of Any Aneurysmal Dilatation in Each Segment (Proximal, Mid- and Distal) in the Right and the Left Renal Arteries Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Right : Proximal | 0.3 percentage of participants |
| Gadobutrol-enhanced MRA | The Presence of Any Aneurysmal Dilatation in Each Segment (Proximal, Mid- and Distal) in the Right and the Left Renal Arteries Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Right : Mid | 1.0 percentage of participants |
| Gadobutrol-enhanced MRA | The Presence of Any Aneurysmal Dilatation in Each Segment (Proximal, Mid- and Distal) in the Right and the Left Renal Arteries Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Right : Distal | 1.4 percentage of participants |
| Gadobutrol-enhanced MRA | The Presence of Any Aneurysmal Dilatation in Each Segment (Proximal, Mid- and Distal) in the Right and the Left Renal Arteries Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Left : Proximal | 0 percentage of participants |
| Gadobutrol-enhanced MRA | The Presence of Any Aneurysmal Dilatation in Each Segment (Proximal, Mid- and Distal) in the Right and the Left Renal Arteries Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Left : Mid | 0.3 percentage of participants |
| Gadobutrol-enhanced MRA | The Presence of Any Aneurysmal Dilatation in Each Segment (Proximal, Mid- and Distal) in the Right and the Left Renal Arteries Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Left : Distal | 0.7 percentage of participants |
| Unenhanced MRA | The Presence of Any Aneurysmal Dilatation in Each Segment (Proximal, Mid- and Distal) in the Right and the Left Renal Arteries Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Left : Mid | 0.3 percentage of participants |
| Unenhanced MRA | The Presence of Any Aneurysmal Dilatation in Each Segment (Proximal, Mid- and Distal) in the Right and the Left Renal Arteries Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Right : Proximal | 0 percentage of participants |
| Unenhanced MRA | The Presence of Any Aneurysmal Dilatation in Each Segment (Proximal, Mid- and Distal) in the Right and the Left Renal Arteries Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Left : Proximal | 0 percentage of participants |
| Unenhanced MRA | The Presence of Any Aneurysmal Dilatation in Each Segment (Proximal, Mid- and Distal) in the Right and the Left Renal Arteries Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Right : Mid | 0 percentage of participants |
| Unenhanced MRA | The Presence of Any Aneurysmal Dilatation in Each Segment (Proximal, Mid- and Distal) in the Right and the Left Renal Arteries Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Left : Distal | 0.3 percentage of participants |
| Unenhanced MRA | The Presence of Any Aneurysmal Dilatation in Each Segment (Proximal, Mid- and Distal) in the Right and the Left Renal Arteries Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA | Right : Distal | 0 percentage of participants |
Secondary
Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced 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: FAS with participants 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 Gadobutrol-Enhanced and Unenhanced MRA Images - Blinded Reader 1 | Non-contrast MRA | 0 participants | 0.8 |
| Gadobutrol-enhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images - Blinded Reader 1 | Contrast-enhanced MRA | 1 participants | 0.8 |
| Gadobutrol-enhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images - Blinded Reader 1 | CTA | 120 participants | 0.8 |
| Gadobutrol-enhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced 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 Gadobutrol-Enhanced and Unenhanced MRA Images - Blinded Reader 1 | DSCA | 0 participants | — |
| Gadobutrol-enhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced 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 Gadobutrol-Enhanced and Unenhanced MRA Images - Blinded Reader 1 | DSCA | 0 participants | — |
| Unenhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images - Blinded Reader 1 | Non-contrast MRA | 2 participants | 0.7 |
| Unenhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images - Blinded Reader 1 | Ultrasound | 0 participants | — |
| Unenhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images - Blinded Reader 1 | Contrast-enhanced MRA | 0 participants | 1 |
| Unenhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced 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 Gadobutrol-Enhanced and Unenhanced MRA Images - Blinded Reader 1 | CTA | 280 participants | 0.9 |
Secondary
Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced 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: FAS with participants 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 Gadobutrol-Enhanced and Unenhanced MRA Images - Blinded Reader 2 | Non-contrast MRA | 0 participants | 0.8 |
| Gadobutrol-enhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images - Blinded Reader 2 | Contrast-enhanced MRA | 0 participants | 0.8 |
| Gadobutrol-enhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images - Blinded Reader 2 | CTA | 39 participants | 0.8 |
| Gadobutrol-enhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images - Blinded Reader 2 | Ultrasound | 1 participants | — |
| Gadobutrol-enhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images - Blinded Reader 2 | DSCA | 1 participants | — |
| Gadobutrol-enhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced 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 Gadobutrol-Enhanced and Unenhanced MRA Images - Blinded Reader 2 | DSCA | 0 participants | — |
| Unenhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images - Blinded Reader 2 | Non-contrast MRA | 0 participants | 0.7 |
| Unenhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images - Blinded Reader 2 | Ultrasound | 1 participants | — |
| Unenhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images - Blinded Reader 2 | Contrast-enhanced MRA | 114 participants | 1 |
| Unenhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced 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 Gadobutrol-Enhanced and Unenhanced MRA Images - Blinded Reader 2 | CTA | 110 participants | 0.9 |
Secondary
Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced 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: FAS with participants 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 Gadobutrol-Enhanced and Unenhanced MRA Images - Blinded Reader 3 | Non-contrast MRA | 0 participants | 0.8 |
| Gadobutrol-enhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images - Blinded Reader 3 | Contrast-enhanced MRA | 1 participants | 0.8 |
| Gadobutrol-enhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images - Blinded Reader 3 | CTA | 22 participants | 0.8 |
| Gadobutrol-enhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced 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 Gadobutrol-Enhanced and Unenhanced MRA Images - Blinded Reader 3 | DSCA | 2 participants | — |
| Gadobutrol-enhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced 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 Gadobutrol-Enhanced and Unenhanced MRA Images - Blinded Reader 3 | DSCA | 0 participants | — |
| Unenhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images - Blinded Reader 3 | Non-contrast MRA | 1 participants | 0.7 |
| Unenhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images - Blinded Reader 3 | Ultrasound | 0 participants | — |
| Unenhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images - Blinded Reader 3 | Contrast-enhanced MRA | 14 participants | 1 |
| Unenhanced MRA | Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced 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 Gadobutrol-Enhanced and Unenhanced MRA Images - Blinded Reader 3 | CTA | 116 participants | 0.9 |
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: FAS with participants 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 | 0 participants | 0.8 |
| 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 | 2 participants | 0.8 |
| Gadobutrol-enhanced MRA | Types of Additional Imaging Studies Recommended by the Clinical Investigator After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images | CTA | 50 participants | 0.8 |
| Gadobutrol-enhanced MRA | Types of Additional Imaging Studies Recommended by the Clinical Investigator After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images | Ultrasound | 0 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 | 3 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 | 1 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 | 0.7 |
| 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 | 114 participants | 1 |
| 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 | 12 participants | 0.9 |
Secondary
Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA 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 artifact presence.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gadobutrol-enhanced MRA | Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 1 | Motion artifact | 17.5 percentage of segments |
| Gadobutrol-enhanced MRA | Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 1 | Saturation artifact | 0.2 percentage of segments |
| Gadobutrol-enhanced MRA | Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 1 | Venous opacification | 4.8 percentage of segments |
| Gadobutrol-enhanced MRA | Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 1 | Other | 5.0 percentage of segments |
| Gadobutrol-enhanced MRA | Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 1 | Susceptibility artifacts | 0.0 percentage of segments |
| Unenhanced MRA | Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 1 | Other | 7.2 percentage of segments |
| Unenhanced MRA | Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 1 | Susceptibility artifacts | 0.1 percentage of segments |
| Unenhanced MRA | Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 1 | Motion artifact | 81.4 percentage of segments |
| Unenhanced MRA | Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 1 | Venous opacification | 15.1 percentage of segments |
| Unenhanced MRA | Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 1 | Saturation artifact | 0.4 percentage of segments |
Secondary
Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA 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 Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 2 | Saturation artifact | 0.2 percentage of segments |
| Gadobutrol-enhanced MRA | Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 2 | Ringing artifact | 0.6 percentage of segments |
| Gadobutrol-enhanced MRA | Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 2 | Venous opacification | 12.0 percentage of segments |
| Gadobutrol-enhanced MRA | Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 2 | Bolus timing error | 1.7 percentage of segments |
| Gadobutrol-enhanced MRA | Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 2 | Susceptibility artifacts | 3.6 percentage of segments |
| Gadobutrol-enhanced MRA | Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 2 | Other | 1.7 percentage of segments |
| Gadobutrol-enhanced MRA | Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 2 | Motion artifact | 5.4 percentage of segments |
| Unenhanced MRA | Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 2 | Other | 6.5 percentage of segments |
| Unenhanced MRA | Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 2 | Motion artifact | 57.1 percentage of segments |
| Unenhanced MRA | Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 2 | Venous opacification | 9.6 percentage of segments |
| Unenhanced MRA | Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 2 | Saturation artifact | 24.4 percentage of segments |
| Unenhanced MRA | Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 2 | Susceptibility artifacts | 6.0 percentage of segments |
| Unenhanced MRA | Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 2 | Ringing artifact | 1.4 percentage of segments |
| Unenhanced MRA | Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 2 | Bolus timing error | 0.1 percentage of segments |
Secondary
Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA 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 Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 3 | Saturation artifact | 3.0 percentage of segments |
| Gadobutrol-enhanced MRA | Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 3 | Ringing artifact | 6.7 percentage of segments |
| Gadobutrol-enhanced MRA | Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 3 | Venous opacification | 14.2 percentage of segments |
| Gadobutrol-enhanced MRA | Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 3 | Bolus timing error | 0.3 percentage of segments |
| Gadobutrol-enhanced MRA | Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 3 | Susceptibility artifacts | 4.0 percentage of segments |
| Gadobutrol-enhanced MRA | Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 3 | Other | 0.7 percentage of segments |
| Gadobutrol-enhanced MRA | Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 3 | Motion artifact | 32.8 percentage of segments |
| Unenhanced MRA | Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 3 | Other | 0.2 percentage of segments |
| Unenhanced MRA | Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 3 | Motion artifact | 96.2 percentage of segments |
| Unenhanced MRA | Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 3 | Venous opacification | 34.5 percentage of segments |
| Unenhanced MRA | Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 3 | Saturation artifact | 56.0 percentage of segments |
| Unenhanced MRA | Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 3 | Susceptibility artifacts | 7.0 percentage of segments |
| Unenhanced MRA | Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 3 | Ringing artifact | 76.7 percentage of segments |
| Unenhanced MRA | Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 3 | Bolus timing error | 1.5 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 the ease of expression, the following abbreviations will be used: Diameter (DIA), Blinded Reader (BR).
Time frame: Images were taken pre-injection and post-injection
Population: Evaluable participants in FAS
| 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 | 5.13 mm | Standard Deviation 0.91 |
| 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 | 2.80 mm | Standard Deviation 1.08 |
| 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 | 4.83 mm | Standard Deviation 1.05 |
| 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 | 2.30 mm | Standard Deviation 0.99 |
| 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 | 5.08 mm | Standard Deviation 1.22 |
| 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 | 2.80 mm | Standard Deviation 1.04 |
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