Subjects with known or suspected vascular disease of the supra-aortic vessels MedDRA version: 14.1 Level: PT Classification code 10007687 Term: Carotid artery stenosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Sponsors
Bayer Health Care AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female subjects, aged 18 years and older - Any of the following: - Known or suspected supra-aortic arterial disease based on: - Prior stroke - Transient ischemic attack (TIA) - Amaurosis Fugax (transient monocular blindness) - Referred for evaluation of any supra-aortic vessel (for clinically significant stenosis) - Follow-up for a stent in a supra-aortic vessel - Prior imaging study (Computed Tomographic Angiography [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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Pregnant or nursing (including pumping for storage and feeding) - Received any other investigational product or participation in any other clinical trial within 30 days before enrollment into this study - Previous enrollment into this study or into any other Bayer sponsored study using gadobutrol - Contraindication to the MRA examinations (e.g. inability to hold breath; severe arrhythmias; very low cardiac output, severe claustrophobia, defibrillators or other metallic devices not approved for MRI) - Contraindication to the use of Gd-containing contrast agents (including subjects with suspicion for or known to have Nephrogenic Systemic Fibrosis [NSF]) - History of severe allergic or anaphylactoid reaction to any allergen including drugs and contrast agents - Received any contrast agent within 72 hours before the study MRA, or scheduled receipt of any contrast agent within 24 hours after the study MRA (Note: This applies also to a CTA potentially scheduled during the course of the study.) - Estimated glomerular filtration rate (eGFR) value < 30 ml/min/1.73 m2 derived from a serum creatinine result within 2 weeks before the gadobutrol injection. Any subject on hemodialysis or peritoneal dialysis is excluded from participation. Use the value obtained prior to and closest to the time of the MRA, if there are multiple creatinine values. (Do not use the core lab value if not available prior to the MRA.) - Acute renal insufficiency of any intensity, either due to hepato-renal syndrome or occurring in the peri-operative liver transplantation period - Severe cardiovascular disease (e.g. acute myocardial infarction [< 14 days], unstable angina, congestive heart failure New York Heart Association class IV) or known long QT syndrome - Suspected clinical instability or unpredictability of the clinical course during the study period (e.g. due to previous surgery) - Scheduled or potentially expected for the period between the CTA and gadobutrol MRA: - Any procedure that may alter the MRA or CTA interpretation, or - Any interventional or surgical procedure involving the supra-aortic vessels
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary efficacy evaluation will be based on three primary efficacy variables: • Assessability • Sensitivity • Specificity which will be calculated for both gadobutrol-enhanced MRA and non-contrast ToF MRA. These will be used to evaluate five co-primary endpoints: - Proportion of assessable vascular segments - Sensitivity for detection of clinically significant disease [70 to 99% stenosis] on a segmental basis - Specificity for exclusion of clinically significant disease [70 to 99% stenosis] on a segmental basis - The two minimum gadobutrol performance criteria: Sensitivity > 50% Specificity > 50% ;Secondary Objective: A further objective of this study is to confirm the safety profile of gadobutrol for this indication. The secondary efficacy assessments will include the following: • Minimum diameter of the segment • Location and length of stenotic segments with = 70% stenosis • Secondary radiologic indicators for diagnosis of clinically significant disease • Artifacts by type (segmental) • Diagnostic confidence (segmental) • Additional imaging studies recommended (example: CTA, CE MRA, Ultrasound, Nuclear Medicine) ;Primary end point(s): The following co-primary efficacy endpoints are based on the proportion of assessable vascular segments, and the sensitivity and specificity of clinically significant disease: - Superiority in the proportion of assessable segments with gadobutrol enhanced MRA compared to non-contrast MRA - Non-inferior detection of clinically significant disease based on sensitivity [70 to 99% stenosis] on a segmental basis - Non-inferior exclusion of clinically significant disease based on specificity [70 to 99% stenosis] on a segmental basis - The two minimum gadobutrol performance criteria (both sensitivity and specificity should exceed 50%);Timepoint(s) of evaluation of this end point: Up to two weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The following secondary efficacy variables will be summarized: - Minimum diameter of the segment - Location and length of stenotic segments with = 70% stenosis - Secondary radiologic indicators for diagnosis of clinically significant disease - Artifacts by type (segmental) - Diagnostic confidence (segmental) - Additional imaging studies recommended (example: CTA, CE MRA, Ultrasound, Nuclear Medicine);Timepoint(s) of evaluation of this end point: Up to two weeks | — |
Countries
Australia, Austria, China, Czech Republic, France, Germany, Italy, Korea, Republic of, Poland, Sweden, Switzerland, Turkey, United States
Contacts
Public ContactBayer Clinical Trials Contact
Bayer HealthCare AG
Outcome results
None listed