Gadobutrol Enhanced MRA of the Supra-aortic Vessels "GEMSAV"

Completed

Phase 3 Results

Trial Description

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

Interventions

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Diagnostic
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Proportion of assessable segments At approximately 15 months after last patient, last visit No
Primary Sensitivity for detection of clinically significant disease (70 to 99% stenosis) on a segmental basis At approximately 15 months after last patient, last visit No
Primary Specificity for exclusion of clinically significant disease (70 to 99% stenosis) on a segmental basis At approximately 15 months after last patient, last visit No
Primary Gadovist minimum performance criteria: Sensitivity > 50% At approximately 15 months after last patient, last visit No
Primary Gadobutrol minimum performance criteria: Specificity > 50% At approximately 15 months after last patient, last visit No
Secondary Minimum diameter of the segment At approximately 15 months after last patient, last visit No
Secondary Location and length of stenotic segments with ≥ 70% stenosis At approximately 15 months after last patient, last visit No
Secondary Secondary radiologic indicators for diagnosis of clinically significant disease At approximately 15 months after last patient, last visit No
Secondary Artifacts by type (segmental) At approximately 15 months after last patient, last visit No
Secondary Diagnostic confidence (segmental) At approximately 15 months after last patient, last visit No
Secondary Additional imaging studies recommended (example: CTA, CE MRA, Ultrasound, Nuclear Medicine) At approximately 15 months after last patient, last visit No
Primary Percentage of Assessable Vascular Segments Using Gadobutrol-Enhanced MRA and Unenhanced MRA Images were taken pre-injection and post-injection No
Primary Sensitivity for Detection of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA Images were taken pre-injection and post-injection No
Primary Specificity for Exclusion of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA Images were taken pre-injection and post-injection No
Primary Minimum Gadobutrol Performance for Sensitivity: Sensitivity > 50% Images were taken pre-injection and post-injection No
Primary Minimum Gadobutrol Performance for Specificity: Specificity > 50% Images were taken pre-injection and post-injection No
Secondary Vessel Diameter (Millimeter [mm]) at the Normal Point and the Narrowest Point in Gadobutrol-Enhanced MRA, Unenhanced MRA and CTA Images Images were taken pre-injection and post-injection No
Secondary The Percentage of Segments With Artifacts Presence Images were taken pre-injection and post-injection No
Secondary Types of Artifacts on a Segment Basis by Blinded Reader 1 Images were taken pre-injection and post-injection No
Secondary Types of Artifacts on a Segment Basis by Blinded Reader 2 Images were taken pre-injection and post-injection No
Secondary Types of Artifacts on a Segment Basis by Blinded Reader 3 Images were taken pre-injection and post-injection No
Secondary The Percentage of Location of Stenosis (>=70%) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA Images were taken pre-injection and post-injection No
Secondary Length of Stenosis (>=70%) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA Images were taken pre-injection and post-injection No
Secondary The Percentage of Presence of Secondary Radiologic Indicators for Diagnosis of Clinically Relevant Disease Images were taken pre-injection and post-injection No
Secondary Type of Secondary Radiologic Indicators for Diagnosis of Clinically Relevant Disease Images were taken pre-injection and post-injection No
Secondary Diagnostic Confidence by the Blinded Readers Using Gadobutrol-Enhanced MRA and Unenhanced MRA Images were taken pre-injection and post-injection No
Secondary 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 Images were taken pre-injection and post-injection No
Secondary Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 1 Images were taken pre-injection and post-injection No
Secondary Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 2 Images were taken pre-injection and post-injection No
Secondary Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 3 Images were taken pre-injection and post-injection No
Secondary Types of Additional Imaging Studies Recommended by the Clinical Investigator After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images Images were taken pre-injection and post-injection No

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