Carotid StenosisPhase 3GEMSAVNCT01344447
Gadobutrol Enhanced MRA of the Supra-aortic Vessels
A Phase 3 study testing Gadobutrol (Gadovist, BAY86-4875) in people with Carotid Stenosis, run by Bayer at 56 sites in 14 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Stenosis
- What is being tested?
- Gadobutrol (Gadovist, BAY86-4875)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 479 participants
- Where
- 56 sitesin 14 countries
- Study dates
- 12 May 2011to 28 May 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects, aged 18 years and older
- Any of the following:
- Known or suspected supra-aortic arterial disease based on:
- Prior stroke
- Transient ischemic attack (TIA)
- Amaurosis Fugax (transient monocular blindness)
Show all 12Show fewer
- Referred for evaluation of any supra-aortic vessel (for clinically significant stenosis)
- Follow-up for a stent in a supra-aortic vessel
- Prior imaging study (CTA or ultrasound) showing ≥ 50% stenosis of a supra-aortic vessel segment (within 60 days before consent). The proportion of subjects with positive disease (determined by the investigator, based on CTA or ultrasound) will be monitored during the study, and enrolment may be further restricted to require ≥ 70% stenosis to ensure that overall there are an adequate number of subjects with clinically significant disease for the evaluation of study endpoints.
- Willingness to undergo the routine Contrast Enhanced Magnetic Resonance Angiography [CE MRA] examination with gadobutrol
- Willingness and ability to follow directions and complete all study procedures specified in the protocol
- Females of childbearing potential only: Negative pregnancy test on the day of the MRA before the administration of study drug
Who cannot join
- Pregnant or nursing (including pumping for storage and feeding)
- Received any other investigational product or participation in any other clinical trial within 30 days before enrollment into this study
- Previous enrollment into this study or into any other Bayer sponsored study using gadobutrol
- Contraindication to the MRA examinations (e.g. inability to hold breath; severe arrhythmias; very low cardiac output, severe claustrophobia, defibrillators or other metallic devices not approved for MRI)
- Contraindication to the use of Gd-containing contrast agents (including subjects with suspicion for or known to have Nephrogenic Systemic Fibrosis [NSF])
- History of severe allergic or anaphylactoid reaction to any allergen including drugs and contrast agents
Show all 14Show fewer
- Received any contrast agent within 72 hours before the study MRA, or scheduled receipt of any contrast agent within 24 hours after the study MRA (Note: This applies also to a CTA potentially scheduled during the course of the study.)
- Estimated glomerular filtration rate (eGFR) value < 30 ml/min/1.73 m2 derived from a serum creatinine result within 2 weeks before the gadobutrol injection. Any subject on hemodialysis or peritoneal dialysis is excluded from participation. Use the value obtained prior to and closest to the time of the MRA, if there are multiple creatinine values. (Do not use the core lab value if not available prior to the MRA.)
- Acute renal insufficiency of any intensity, either due to hepato-renal syndrome or occurring in the peri-operative liver transplantation period
- Severe cardiovascular disease (e.g. acute myocardial infarction [< 14 days], unstable angina, congestive heart failure New York Heart Association class IV) or known long QT syndrome
- Suspected clinical instability or unpredictability of the clinical course during the study period (e.g. due to previous surgery)
- Scheduled or potentially expected for the period between the CTA and gadobutrol MRA:
- Any procedure that may alter the MRA or CTA interpretation, or
- Any interventional or surgical procedure involving the supra-aortic vessels
Trial locations and contacts
56 sites in 14 countries.
56 sites in 14 countries
United States15 sites
Study site
Ann Arbor, Michigan, 48109-0330
Study site
Baltimore, Maryland, 21201
Study site
Boston, Massachusetts, 02114
Study site
Jackson, Mississippi, 39216
Study site
Jacksonville, Florida, 32209
Study site
Louisville, Kentucky, 40202
Study site
Madison, Wisconsin, 53792
Study site
Memphis, Tennessee, 38104
Study site
Philadelphia, Pennsylvania, 19104
Study site
Providence, Rhode Island, 02903
Study site
Rochester, New York, 14642
Study site
Savannah, Georgia, 31406
Study site
Seattle, Washington, 98195
Study site
The Bronx, New York, 10467
Study site
Tucson, Arizona, 85724
Italy6 sites
Study site
Aosta, Aosta Valley, 11100
Study site
Catania, Sicily, 95123
Study site
Ferrara, Emilia-Romagna, 44023
Study site
Massa-Carrara, Tuscany, 54100
Study site
Rome, Lazio, 00168
Study site
Venezia, Veneto, 30174
France5 sites
Study site
Brest, 29609
Study site
Bron, 69677
Study site
Marseille, 13385
Study site
Paris, 75877
Study site
Paris, 75908
Germany5 sites
Study site
Augsburg, Bavaria, 865156
Study site
Erlangen, Bavaria, 91054
Study site
Jena, Thuringia, 07740
Study site
Karlsruhe, Baden-Wurttemberg, 76133
Study site
Münster, North Rhine-Westphalia, 48145
Poland4 sites
Study site
Bydgoszcz, 85-094
Study site
Lodz, 90-153
Study site
Warsaw, 02-097
Study site
Wroclaw, 50-556
South Korea4 sites
Study site
Donggu, Gwangju Gwang''yeogsi, 61469
Study site
Seoul, 03722
Study site
Seoul, 05505
Study site
Seoul, 06351
Argentina3 sites
Study site
Adrogué, Buenos Aires, B1846DWA
Study site
Buenos Aires, Ciudad Auton. de Buenos Aires, C1115AAB
Study site
Buenos Aires, Ciudad Auton. de Buenos Aires, C1425BEE
Australia3 sites
Study site
Clayton, Victoria, 3168
Study site
New Lambton Heights, New South Wales, 2305
Study site
Parkville, Victoria, 3052
Turkey (Türkiye)3 sites
Study site
Antalya, 07059
Study site
Erzurum, 25240
Study site
Istanbul, 34093
About this study
Official title: Multicenter, Open-label Study to Evaluate the Safety and Efficacy (by Blinded Reading) of Contrast-Enhanced Magnetic Resonance Angiography (MRA) After a Single Intravenous Injection of 0.1 mmol/kg Gadobutrol in Subjects With Known or Suspected Vascular Disease of the Supra-aortic Vessels
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).
- Conditions
- Carotid Stenosis
- Being tested
- Gadobutrol (Gadovist, BAY86-4875)
- Keywords
- Supra-aortic vascular disease, MRA, CTA, Males and females aged 18 years or older, Stroke, Transient Ischemic Attack (TIA)
- Medical subject headings
- Carotid Stenosis, Stroke, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gadobutrol (Gadovist, BAY86-4875)Drug
A single bolus injection of approx. 0.1mmol/kg
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Gadobutrol (Gadovist, BAY86-4875) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Assessable Vascular Segments Using Gadobutrol-Enhanced MRA and Unenhanced MRA
Each vascular segment was visualized using unenhanced MRA and gadobutrol-enhanced MRA, characterized by the on-site investigators, three independent blinded readers (BR) (BR 1, BR 2 and BR 3) and majority readers (the outcome determined by at least two of the blinded readers). A segment was assessable if it was visualized along its entire length and if any region of stenosis, was measured reliably. There were 21 segments of the supra-aortic arteries assessed per participant.
Measured: 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 70 to 99% stenosis of a segment, but not occluded, as assessed by the standard of reference (SoR) (computed tomographic angiography [CTA]; blinded readers). This was determined using the North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria. For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. In case of multiple stenosis in any one segment, the most severe stenosis in the segment was recorded.
Measured: 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 was defined as 70 to 99% stenosis of a segment, but not occluded, as assessed by the SoR (CTA; blinded readers). This was determined using the NASCET criteria. For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. In case of multiple stenosis in any one segment, the most severe stenosis in the segment was recorded.
Measured: Images were taken pre-injection and post-injection
Minimum Gadobutrol Performance for Sensitivity: Sensitivity > 50%
Clinically significant disease was defined as 70 to 99% stenosis of a segment, but not occluded as assessed by the SoR (CTA; blinded readers). For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. Gadobutrol minimum performance criteria was based on a stenosis of 50% calculated from the native vessel diameter.
Measured: Images were taken pre-injection and post-injection
Minimum Gadobutrol Performance for Specificity: Specificity > 50%
Clinically significant disease was defined as 70 to 99% stenosis of a segment, but not occluded as assessed by the SoR (CTA; blinded readers). For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. Gadobutrol minimum performance criteria was based on a stenosis of 50% calculated from the native vessel diameter.
Measured: Images were taken pre-injection and post-injection
Secondary outcomes (15)
Vessel Diameter (Millimeter [mm]) at the Normal Point and the Narrowest Point in Gadobutrol-Enhanced MRA, Unenhanced MRA and CTA Images
The segment reduction in diameter (DIA) of greater than 10% was considered abnormal and measured. The diameter of each of these abnormal segments was measured using electronic calipers (perpendicular to the long axis of the vessel) at the point of most severe stenosis within each segment. Mean of vessel diameters was calculated by segment separately for CTA and MRA readers. For ease of expression, the following abbreviations will be used: Diameter (DIA), Blinded Reader (BR), Clinical Investigator (CI).
Measured: 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.
Measured: Images were taken pre-injection and post-injection
Types of Artifacts on a Segment Basis by Blinded Reader 1
The following types of artifacts were considered: Motion artifact (including pulsatility, breathing, swallowing), venous opacification, saturation artifact (for example [eg], in-plane flow, turbulence, dephasing, saturation band), susceptibility artifacts (including devices, eg, stents), ringing artifact (eg, bands), bolus timing error, and other (artifact not specified above or no artifact).
Measured: Images were taken pre-injection and post-injection
Types of Artifacts on a Segment Basis by Blinded Reader 2
The following types of artifacts were considered: Motion artifact (including pulsatility, breathing, swallowing), venous opacification, saturation artifact (for example [eg], in-plane flow, turbulence, dephasing, saturation band), susceptibility artifacts (including devices, eg, stents), ringing artifact (eg, bands), bolus timing error, and other (artifact not specified above or no artifact).
Measured: Images were taken pre-injection and post-injection
Types of Artifacts on a Segment Basis by Blinded Reader 3
The following types of artifacts were considered: Motion artifact (including pulsatility, breathing, swallowing), venous opacification, saturation artifact (for example [eg], in-plane flow, turbulence, dephasing, saturation band), susceptibility artifacts (including devices, eg, stents), ringing artifact (eg, bands), bolus timing error, and other (artifact not specified above or no artifact).
Measured: Images were taken pre-injection and post-injection
The Percentage of Location of Stenosis (>=70%) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA
Location within a segment was based on the point of greatest stenosis and was recorded for stenosis >=70% (including occlusions) as: - At the bifurcation or proximal origin of a segment (occlusion proximal to the origin of the segment); - Within 5 mm of the bifurcation or proximal origin of a segment; - Beyond 5 mm from the bifurcation or proximal origin of a segment.
Measured: Images were taken pre-injection and post-injection
Length of Stenosis (>=70%) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA
The length of stenosis was based on the most proximal (first point) in a segment where a stenosis exceeded 10% and the most distal point (last point) in the segment where a stenosis exceeded 10%. If a stenosis spanned more than one segment then the measurement was only included to the beginning or end (boundary) of the segment being evaluated. If there was no stenosis of >=70% in a segment then the length was designated as 0.
Measured: Images were taken pre-injection and post-injection
The Percentage of Presence of Secondary Radiologic Indicators for Diagnosis of Clinically Relevant Disease
Each segment was assessed for secondary signs of stenosis for diagnosis of clinically significant disease. The following indicators were considered for the MRA studies: - post-stenotic dilation or ulceration (segmental), - post-stenotic signal dropout, narrowing and intensity reduction, and - thrombus. Each of the three parameters were assessed as present or absent in the region distal to the stenosis. If they were found in any segment distal to the stenosis then they were assessed as present.
Measured: Images were taken pre-injection and post-injection
Type of Secondary Radiologic Indicators for Diagnosis of Clinically Relevant Disease
Each segment was assessed for secondary signs of stenosis for diagnosis of clinically significant disease. The following indicators were considered for the MRA studies: - post-stenotic dilation or ulceration (segmental), - post-stenotic signal dropout, narrowing and intensity reduction, and - thrombus. Each of the three parameters were assessed as present or absent in the region distal to the stenosis. If they were found in any segment distal to the stenosis then they were assessed as present. If there were tandem (serial) stenosis in a vessel then the secondary signs were assigned to the stenosis of >=70% that was proximal and closest in proximity to the secondary sign.
Measured: 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, and 4 = Very confident.
Measured: 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 Unenhanced and Gadobutrol-Enhanced MRA Images
A measure of diagnostic value was the reduction in the number of additional diagnostic imaging studies recommended/ordered. The clinical investigators and the blinded readers were asked if they would have recommended an additional imaging study for each participant and was recorded.
Measured: Images were taken pre-injection and post-injection
Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 1
An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.
Measured: Images were taken pre-injection and post-injection
Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 2
An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.
Measured: Images were taken pre-injection and post-injection
Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 3
An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.
Measured: 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.
Measured: Images were taken pre-injection and post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2011 (estimated)
- Study start12 May 2011
- Primary completion28 May 2014
- Study completion28 May 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Carotid StenosisStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 479 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01344447
- Sponsor's protocol ID
- 14607
- Other IDs
- 2010-023001-36
- Acronym
- GEMSAV
- Status last verified
- Dec 2018
- First submitted
- 5 Apr 2011
- Last updated
- 4 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Open-label Study to Evaluate the Safety and Efficacy (by Blinded Reading) of Contrast-Enhanced Magnetic Resonance Angiography (MRA) After a Single Intravenous Injection of 0.1 mmol/kg Gadobutrol in Subjects With Known or Suspected Vascular Disease of the Supra-aortic Vessels
- ClinicalTrials.gov ID
- NCT01344447
- Acronym / sponsor ID
- GEMSAV / 14607
- Conditions
- Carotid Stenosis
- Keywords
- Supra-aortic vascular disease, MRA, CTA, Males and females aged 18 years or older, Stroke, Transient Ischemic Attack (TIA)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 479 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 12 May 2011 (actual)
- Primary completion
- 28 May 2014 (actual)
- Study completion
- 28 May 2014 (actual)
- First posted
- 29 Apr 2011 (estimated)
- Results
- Posted 26 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Gadobutrol (Gadovist, BAY86-4875) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female subjects, aged 18 years and older
- Any of the following:
- Willingness to undergo the routine Contrast Enhanced Magnetic Resonance Angiography [CE MRA] examination with gadobutrol
- Willingness and ability to follow directions and complete all study procedures specified in the protocol
- Females of childbearing potential only: Negative pregnancy test on the day of the MRA before the administration of study drug
Key exclusion criteria (14 listed)
- Pregnant or nursing (including pumping for storage and feeding)
- Received any other investigational product or participation in any other clinical trial within 30 days before enrollment into this study
- Previous enrollment into this study or into any other Bayer sponsored study using gadobutrol
- Contraindication to the MRA examinations (e.g. inability to hold breath; severe arrhythmias; very low cardiac output, severe claustrophobia, defibrillators or other metallic devices not approved for MRI)
- Contraindication to the use of Gd-containing contrast agents (including subjects with suspicion for or known to have Nephrogenic Systemic Fibrosis [NSF])
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gadobutrol (Gadovist, BAY86-4875)A single bolus injection of approx. 0.1mmol/kg | Drug | Arm 1 |
Primary outcome
Percentage of Assessable Vascular Segments Using Gadobutrol-Enhanced MRA and Unenhanced MRA
Time frame: Images were taken pre-injection and post-injection
Each vascular segment was visualized using unenhanced MRA and gadobutrol-enhanced MRA, characterized by the on-site investigators, three independent blinded readers (BR) (BR 1, BR 2 and BR 3) and majority readers (the outcome determined by at least two of the blinded readers). A segment was assessable if it was visualized along its entire length and if any region of stenosis, was measured reliably. There were 21 segments of the supra-aortic arteries assessed per participant.
Sensitivity for Detection of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA
Time frame: Images were taken pre-injection and post-injection
Clinically significant disease was defined as 70 to 99% stenosis of a segment, but not occluded, as assessed by the standard of reference (SoR) (computed tomographic angiography [CTA]; blinded readers). This was determined using the North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria. For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. In case of multiple stenosis in any one segment, the most severe stenosis in the segment was recorded.
Specificity for Exclusion of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA
Time frame: Images were taken pre-injection and post-injection
Clinically significant disease was defined as 70 to 99% stenosis of a segment, but not occluded, as assessed by the SoR (CTA; blinded readers). This was determined using the NASCET criteria. For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. In case of multiple stenosis in any one segment, the most severe stenosis in the segment was recorded.
Minimum Gadobutrol Performance for Sensitivity: Sensitivity > 50%
Time frame: Images were taken pre-injection and post-injection
Clinically significant disease was defined as 70 to 99% stenosis of a segment, but not occluded as assessed by the SoR (CTA; blinded readers). For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. Gadobutrol minimum performance criteria was based on a stenosis of 50% calculated from the native vessel diameter.
Minimum Gadobutrol Performance for Specificity: Specificity > 50%
Time frame: Images were taken pre-injection and post-injection
Clinically significant disease was defined as 70 to 99% stenosis of a segment, but not occluded as assessed by the SoR (CTA; blinded readers). For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. Gadobutrol minimum performance criteria was based on a stenosis of 50% calculated from the native vessel diameter.
15 secondary outcomes
Vessel Diameter (Millimeter [mm]) at the Normal Point and the Narrowest Point in Gadobutrol-Enhanced MRA, Unenhanced MRA and CTA Images
Time frame: Images were taken pre-injection and post-injection
The Percentage of Segments With Artifacts Presence
Time frame: Images were taken pre-injection and post-injection
Types of Artifacts on a Segment Basis by Blinded Reader 1
Time frame: Images were taken pre-injection and post-injection
Types of Artifacts on a Segment Basis by Blinded Reader 2
Time frame: Images were taken pre-injection and post-injection
Types of Artifacts on a Segment Basis by Blinded Reader 3
Time frame: Images were taken pre-injection and post-injection
The Percentage of Location of Stenosis (>=70%) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA
Time frame: Images were taken pre-injection and post-injection
Length of Stenosis (>=70%) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA
Time frame: Images were taken pre-injection and post-injection
The Percentage of Presence of Secondary Radiologic Indicators for Diagnosis of Clinically Relevant Disease
Time frame: Images were taken pre-injection and post-injection
Type of Secondary Radiologic Indicators for Diagnosis of Clinically Relevant Disease
Time frame: Images were taken pre-injection and post-injection
Diagnostic Confidence by the Blinded Readers Using Gadobutrol-Enhanced MRA and Unenhanced MRA
Time frame: 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 Unenhanced and Gadobutrol-Enhanced MRA Images
Time frame: Images were taken pre-injection and post-injection
Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 1
Time frame: Images were taken pre-injection and post-injection
Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 2
Time frame: Images were taken pre-injection and post-injection
Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 3
Time frame: 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
Time frame: Images were taken pre-injection and post-injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Click here to find information about studies related to Bayer Healthcare products conducted in EuropeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
56 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gadobutrol (Gadovist, BAY86-4875) in people with Carotid Stenosis, run by Bayer at 56 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in United States, Italy, France, Germany, Poland and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Assessable Vascular Segments Using Gadobutrol-Enhanced MRA and Unenhanced MRA (time frame: Images were taken pre-injection and post-injection). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2019.