Woman and Man
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Extract
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%
Inclusion criteria
- Subjects with known or suspected vascular disease of the supra-aortic vessels