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Gadobutrol Enhanced MRA of the Renal Arteries (GRAMS)

Primary Purpose

Renal Artery Obstruction

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Gadobutrol (Gadovist, BAY86-4875)
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Renal Artery Obstruction focused on measuring magnetic resonance angiography (MRA) of the renal arteries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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).
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.
The Percentage of Segments With Artifacts Presence
Artifacts were collected for the MRA images on a segmental basis.
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).
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
April 5, 2011
Last Updated
July 29, 2015
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT01344460
Brief Title
Gadobutrol Enhanced MRA of the Renal Arteries
Acronym
GRAMS
Official Title
Multicenter, Open-label Study to Evaluate the Safety and Efficacy (by Blinded Reading) of Gadobutrol-enhanced Magnetic Resonance Angiography (MRA) After a Single Injection of 0.1 mmol/kg of Gadobutrol in Subjects With Known or Suspected Renal Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Artery Obstruction
Keywords
magnetic resonance angiography (MRA) of the renal arteries

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
317 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Gadobutrol (Gadovist, BAY86-4875)
Intervention Description
a single bolus injection of approx. 0.1mmol/kg
Primary Outcome Measure Information:
Title
Percentage of Assessable Vascular Segments Using Gadobutrol-Enhanced MRA and Unenhanced MRA
Description
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
Title
Sensitivity for Detection of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA
Description
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
Title
Specificity for Exclusion of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA
Description
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
Title
Minimum Gadobutrol Performance for Sensitivity: Sensitivity More Than (>) 50%
Description
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
Title
Minimum Gadobutrol Performance for Specificity: Specificity > 50%
Description
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
Secondary Outcome Measure Information:
Title
Length of the Right and Left Renal Arteries Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA - Blinded Reader
Description
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
Title
Length of the Right and Left Renal Arteries Assessed by Computed Tomographic Angiography (CTA) - Blinded Reader
Description
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
Title
Vessel Diameter (Millimeter [mm]) at the Normal Point and the Narrowest Point in Gadobutrol-Enhanced MRA, Unenhanced MRA and CTA Images
Description
The segment reduction in diameter (DIA) of greater than 10% was considered abnormal and measured. The diameter of each of these abnormal segments was measured using electronic calipers (perpendicular to the long axis of the vessel) at the point of most severe stenosis within each segment. Mean of vessel diameters was calculated by segment separately for CTA and MRA readers. For 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
Title
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
Description
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
Title
The Percentage of Segments With Artifacts Presence
Description
Artifacts were collected for the MRA images on a segmental basis.
Time Frame
Images were taken pre-injection and post-injection
Title
Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 1
Description
The following types of artifacts were considered: Motion artifact (including pulsatility, breathing, swallowing), venous opacification, saturation artifact (for example [eg], in-plane flow, turbulence, dephasing, saturation band), susceptibility artifacts (including devices, eg, stents), ringing artifact (eg, bands), bolus timing error, and other (artifact not specified above or no artifact).
Time Frame
Images were taken pre-injection and post-injection
Title
Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 2
Description
The following types of artifacts were considered: Motion artifact (including pulsatility, breathing, swallowing), venous opacification, saturation artifact (for example [eg], in-plane flow, turbulence, dephasing, saturation band), susceptibility artifacts (including devices, eg, stents), ringing artifact (eg, bands), bolus timing error, and other (artifact not specified above or no artifact).
Time Frame
Images were taken pre-injection and post-injection
Title
Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 3
Description
The following types of artifacts were considered: Motion artifact (including pulsatility, breathing, swallowing), venous opacification, saturation artifact (for example [eg], in-plane flow, turbulence, dephasing, saturation band), susceptibility artifacts (including devices, eg, stents), ringing artifact (eg, bands), bolus timing error, and other (artifact not specified above or no artifact).
Time Frame
Images were taken pre-injection and post-injection
Title
The Percentage of Accessory (Non-dominant) Renal Artery Presence Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA
Description
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
Title
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
Description
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
Title
The Percentage of Participants With Diagnosis of Fibromuscular Dysplasia and Arteriosclerosis Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA
Description
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
Title
Diagnostic Confidence by the Blinded Readers Using Gadobutrol-Enhanced MRA and Unenhanced MRA
Description
Diagnostic confidence was evaluated to determine the level of certainty that the blinded readers assigned to a diagnosis for each segment. This was defined as the degree of confidence that the information on the MRA images represented the true and complete clinical picture of a particular segment. The degree of confidence was rated on a 4-point scale: 1=Not confident; 2=Somewhat confident; 3=Confident; 4=Very confident.
Time Frame
Images were taken pre-injection and post-injection
Title
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
Description
A measure of diagnostic value was the reduction in the number of additional diagnostic imaging studies recommended/ordered. The clinical investigators and the blinded readers were asked if they had recommended an additional imaging study for each participant, and the data were recorded.
Time Frame
Images were taken pre-injection and post-injection
Title
Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images - Blinded Reader 1
Description
An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.
Time Frame
Images were taken pre-injection and post-injection
Title
Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images - Blinded Reader 2
Description
An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.
Time Frame
Images were taken pre-injection and post-injection
Title
Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images - Blinded Reader 3
Description
An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.
Time Frame
Images were taken pre-injection and post-injection
Title
Types of Additional Imaging Studies Recommended by the Clinical Investigator After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images
Description
An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.
Time Frame
Images were taken pre-injection and post-injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
City
Orange
State/Province
California
ZIP/Postal Code
92660
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903-4900
Country
United States
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3900
Country
United States
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
City
Adrogué
State/Province
Buenos Aires
ZIP/Postal Code
B1846DWA
Country
Argentina
City
Buenos Aires
State/Province
Ciudad Auton. de Buenos Aires
ZIP/Postal Code
C1425BEE
Country
Argentina
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000DTC
Country
Argentina
City
Innsbruck
State/Province
Tirol
ZIP/Postal Code
6020
Country
Austria
City
Wiener Neustadt
ZIP/Postal Code
2700
Country
Austria
City
Wien
ZIP/Postal Code
1090
Country
Austria
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90035-001
Country
Brazil
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
05651-901
Country
Brazil
City
Rio de Janeiro
ZIP/Postal Code
22281-100
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
04023-061
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
05403-900
Country
Brazil
City
Medellín
State/Province
Antioquia
Country
Colombia
City
Barranquilla
State/Province
Atlántico
Country
Colombia
City
Cali
State/Province
Valle del Cauca
Country
Colombia
City
Bogotá
Country
Colombia
City
Brno
ZIP/Postal Code
625 00
Country
Czech Republic
City
Olomouc
ZIP/Postal Code
775 20
Country
Czech Republic
City
Plzen
ZIP/Postal Code
304 60
Country
Czech Republic
City
Praha 2
ZIP/Postal Code
12808
Country
Czech Republic
City
Praha 5
ZIP/Postal Code
150 30
Country
Czech Republic
City
La Tronche
ZIP/Postal Code
38700
Country
France
City
Paris Cedex 13
ZIP/Postal Code
75651
Country
France
City
Paris
ZIP/Postal Code
75877
Country
France
City
Paris
ZIP/Postal Code
75908
Country
France
City
Rouen Cedex
ZIP/Postal Code
76031
Country
France
City
Vandoeuvre-les-nancy
ZIP/Postal Code
54500
Country
France
City
Karlsruhe
State/Province
Baden-Württemberg
ZIP/Postal Code
76133
Country
Germany
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60596
Country
Germany
City
Münster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48145
Country
Germany
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
City
Lübeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23538
Country
Germany
City
Jena
State/Province
Thüringen
ZIP/Postal Code
07740
Country
Germany
City
Berlin
ZIP/Postal Code
12351
Country
Germany
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
110-744
Country
Korea, Republic of
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
135-720
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
City
Seoul
Country
Korea, Republic of
City
Suwon
ZIP/Postal Code
443-721
Country
Korea, Republic of
City
Krakow
ZIP/Postal Code
31-02
Country
Poland
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
City
Basel
State/Province
Basel-Stadt
ZIP/Postal Code
4031
Country
Switzerland
City
Olten
State/Province
Solothurn
ZIP/Postal Code
4600
Country
Switzerland
City
Bern
ZIP/Postal Code
CH-3010
Country
Switzerland
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
City
Kaoshiung
ZIP/Postal Code
81346
Country
Taiwan
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
City
Taipei
ZIP/Postal Code
116
Country
Taiwan
City
Taipei
Country
Taiwan
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Links:
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Learn more about this trial

Gadobutrol Enhanced MRA of the Renal Arteries

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