Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023002-13 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gadobutrol (Gadovist, BAY86-4875) | Drug | a single bolus injection of approx. 0.1mmol/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Images were taken pre-injection and post-injection |
| 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. | Images were taken pre-injection and post-injection |
| 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. | Images were taken pre-injection and post-injection |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Male or female subjects, aged ≥ 18 years
Known or suspected renal artery disease based on any of the following:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tucson | Arizona | 85711 | United States | |||
Not provided
| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe | View source |
Not provided
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.
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).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Images were taken pre-injection and post-injection |
| 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. | Images were taken pre-injection and post-injection |
| Images were taken pre-injection and post-injection |
| 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. | Images were taken pre-injection and post-injection |
| 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). | Images were taken pre-injection and post-injection |
| 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. | Images were taken pre-injection and post-injection |
| The Percentage of Segments With Artifacts Presence | Artifacts were collected for the MRA images on a segmental basis. | Images were taken pre-injection and post-injection |
| 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). | Images were taken pre-injection and post-injection |
| 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). | Images were taken pre-injection and post-injection |
| 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). | Images were taken pre-injection and post-injection |
| 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. | Images were taken pre-injection and post-injection |
| 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. | Images were taken pre-injection and post-injection |
| 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. | Images were taken pre-injection and post-injection |
| 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. | Images were taken pre-injection and post-injection |
| 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. | Images were taken pre-injection and post-injection |
| 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. | Images were taken pre-injection and post-injection |
| 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. | Images were taken pre-injection and post-injection |
| 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. | Images were taken pre-injection and post-injection |
| 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. | Images were taken pre-injection and post-injection |
| Los Angeles |
| California |
| 90033 |
| United States |
| Los Angeles | California | 90095 | United States |
| Orange | California | 92660 | United States |
| Jacksonville | Florida | 32209 | United States |
| Miami | Florida | 33136 | United States |
| Savannah | Georgia | 31406 | United States |
| Chicago | Illinois | 60611 | United States |
| Baltimore | Maryland | 21287 | United States |
| Durham | North Carolina | 27710 | United States |
| Providence | Rhode Island | 02903-4900 | United States |
| Memphis | Tennessee | 38104 | United States |
| San Antonio | Texas | 78229-3900 | United States |
| Madison | Wisconsin | 53705 | United States |
| Milwaukee | Wisconsin | 53215 | United States |
| Adrogué | Buenos Aires | B1846DWA | Argentina |
| Buenos Aires | Ciudad Auton. de Buenos Aires | C1425BEE | Argentina |
| Rosario | Santa Fe Province | S2000DTC | Argentina |
| Innsbruck | Tyrol | 6020 | Austria |
| Vienna | 1090 | Austria |
| Wiener Neustadt | 2700 | Austria |
| Rio de Janeiro | Rio de Janeiro | 22281-100 | Brazil |
| Porto Alegre | Rio Grande do Sul | 90035-001 | Brazil |
| São Paulo | São Paulo | 04023-061 | Brazil |
| São Paulo | São Paulo | 05403-000 | Brazil |
| São Paulo | São Paulo | 05403-900 | Brazil |
| São Paulo | São Paulo | 05651-901 | Brazil |
| Medellín | Antioquia | Colombia |
| Barranquilla | Atlántico | Colombia |
| Cali | Valle del Cauca Department | Colombia |
| Bogotá | Colombia |
| Brno | 625 00 | Czechia |
| Olomouc | 775 20 | Czechia |
| Pilsen | 304 60 | Czechia |
| Prague | 12808 | Czechia |
| Prague | 150 30 | Czechia |
| La Tronche | 38700 | France |
| Paris | 75651 | France |
| Paris | 75877 | France |
| Paris | 75908 | France |
| Rouen | 76031 | France |
| Vandœuvre-lès-Nancy | 54500 | France |
| Karlsruhe | Baden-Wurttemberg | 76133 | Germany |
| Frankfurt am Main | Hesse | 60596 | Germany |
| Münster | North Rhine-Westphalia | 48145 | Germany |
| Kiel | Schleswig-Holstein | 24105 | Germany |
| Lübeck | Schleswig-Holstein | 23538 | Germany |
| Berlin | State of Berlin | 12351 | Germany |
| Jena | Thuringia | 07740 | Germany |
| Krakow | 31-02 | Poland |
| Lodz | 90-153 | Poland |
| Lublin | 20-090 | Poland |
| Warsaw | 02-097 | Poland |
| Seoul | Seoul Teugbyeolsi | 110-744 | South Korea |
| Seoul | Seoul Teugbyeolsi | 135-720 | South Korea |
| Seoul | 135-710 | South Korea |
| Seoul | South Korea |
| Suwon | 443-721 | South Korea |
| Basel | Canton of Basel-City | 4031 | Switzerland |
| Bern | Canton of Bern | CH-3010 | Switzerland |
| Olten | Canton of Solothurn | 4600 | Switzerland |
| Zurich | Canton of Zurich | 8091 | Switzerland |
| Taipei | Taipei | 116 | Taiwan |
| Kaoshiung | 81346 | Taiwan |
| Taipei | 11217 | Taiwan |
| Taipei | Taiwan |
| Taoyuan | 333 | Taiwan |
| Ankara | 06500 | Turkey (Türkiye) |
| Istanbul | 34098 | Turkey (Türkiye) |
| Istanbul | Turkey (Türkiye) |
| Fulfilled Requirements of FAS Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Age, Customized | Number | participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Baseline Weight | Mean | Standard Deviation | kilogram(s) |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | FAS; in below table, "n/n" signifies the number of participants/segments that were evaluable in specified category for both groups. | Posted | Number | Percentage of segments | Images were taken pre-injection and post-injection | segments | Participants |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | FAS; in below table, "n/n" signifies the number of participants/segments that were evaluable in specified category. | Posted | Number | percentage of sensitivity | Images were taken pre-injection and post-injection | segments | Participants |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | FAS; in below table, "n/n" signifies the number of participants/segments that were evaluable in specified category. | Posted | Number | percentage of specificity | Images were taken pre-injection and post-injection | segments | Participants |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | FAS; in below table, "n/n" signifies the number of participants/segments that were evaluable in specified category. | Posted | Number | percentage of sensitivity | Images were taken pre-injection and post-injection | segments | Participants |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | FAS; in below table, "n/n" signifies the number of participants/segments that were evaluable in specified category. | Posted | Number | percentage of specificity | Images were taken pre-injection and post-injection | segments | Participants |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Evaluable participants in FAS | Posted | Mean | Standard Deviation | millimeter(s) (mm) | Images were taken pre-injection and post-injection |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Evaluable participants in FAS | Posted | Mean | Standard Deviation | millimeter(s) (mm) | Images were taken pre-injection and post-injection |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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). | Evaluable participants in FAS | Posted | Mean | Standard Deviation | mm | Images were taken pre-injection and post-injection | segments | Participants |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Participants in FAS that were evaluable; in below table, "n" signifies the number of segments that were evaluable in specified category. | Posted | Number | Percentage of location | Images were taken pre-injection and post-injection |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Percentage of Segments With Artifacts Presence | Artifacts were collected for the MRA images on a segmental basis. | Evaluable participants in FAS | Posted | Number | percentage of segments | Images were taken pre-injection and post-injection |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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). | Participants in FAS with artifact presence. | Posted | Number | percentage of segments | Images were taken pre-injection and post-injection |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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). | Participants in FAS with artifacts presence. | Posted | Number | percentage of segments | Images were taken pre-injection and post-injection |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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). | Participants in FAS with artifacts presence. | Posted | Number | percentage of segments | Images were taken pre-injection and post-injection |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | FAS | Posted | Number | percentage of accessory | Images were taken pre-injection and post-injection |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | FAS | Posted | Number | percentage of participants | Images were taken pre-injection and post-injection |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | FAS | Posted | Number | percentage of participants | Images were taken pre-injection and post-injection |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | FAS; In the below table, "n" signifies the number of segments that were evaluable in specified category. | Posted | Mean | Standard Deviation | Units on scale | Images were taken pre-injection and post-injection |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | FAS | Posted | Number | percentage of participants | Images were taken pre-injection and post-injection |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | FAS with participants who were recommended for additional imaging studies. | Posted | Number | participants | Images were taken pre-injection and post-injection |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | FAS with participants who were recommended for additional imaging studies. | Posted | Number | participants | Images were taken pre-injection and post-injection |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | FAS with participants who were recommended for additional imaging studies. | Posted | Number | participants | Images were taken pre-injection and post-injection |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | FAS with participants who were recommended for additional imaging studies. | Posted | Number | participants | Images were taken pre-injection and post-injection |
|
|
AEs were assessed from the time the consent was signed until 72 (±6) hours follow-up after the study MRA and continued until the end of the study (either the 72 hour follow-up or the CTA, if performed after the MRA as part of the study).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 315 | 14 | 315 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (15.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (15.1) | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | BAYER | clinical-trials-contact@bayerhealthcare.com |
| ID | Term |
|---|---|
| D012078 | Renal Artery Obstruction |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C090600 | gadobutrol |
Not provided
Not provided
Not provided
| >= 65 years |
|
| Blinded reader 2 (n=292/1752) |
|
| Blinded reader 3 (n=292/1734) |
|
| Clinical investigators (n=292/1764) |
|
|
Blinded reader 1; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA. |
| McNemar |
Cluster adjusted McNemar |
| <0.000 |
| Percentage difference |
| 16.4 |
| 2-Sided |
| 95 |
| 13.2 |
Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study. |
| No |
| Superiority or Other |
| Blinded reader 2; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA. | McNemar | Cluster adjusted McNemar | <0.000 | Percentage difference | 24.0 | 2-Sided | 95 | 20.5 | Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study. | No | Superiority or Other |
| Blinded reader 3; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA. | McNemar | <0.000 | Percentage difference | 17.4 | 2-Sided | 95 | 14.3 | Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study. | No | Superiority or Other |
| Clinical investigator; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA. | McNemar | <0.000 | Percentage difference | 25.6 | 2-Sided | 95 | 21.9 | Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study. | No | Superiority or Other |
| segments |
|
|
|
| segments |
|
|
|
| segments |
|
|
|
| segments |
|
|
|
|
|
| segments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|