Extract

The primary efficacy objectives of this study are to demonstrate that sensitivity and specificity of gadobutrol-enhanced CMRI exceed pre-specified minimum performance thresholds (MPT) of 60 and 55%, respectively and to show superior sensitivity over unenhanced wall motion CMRI at vasodilator rest/stress for the detection of significant CAD: Primary objectives (i.e. 3 co-primaries) are to 1) demonstrate that subject-based sensitivity of gadobutrol-enhanced CMRI at vasodilator stress/rest (lower bound of 95% CI) exceeds the predefined minimum performance threshold of 60%; 2) demonstrate that subject-based specificity of gadobutrol-enhanced CMRI at vasodilator stress/rest (lower bound of 95% CI) exceeds the predefined minimum performance threshold of 55%; 3) demonstrate subject-based superior sensitivity of gadobutrol-enhanced CMRI over unenhanced wall motion CMRI.

Inclusion criteria

• Subjects with known or suspected Coronary Artery Disease (CAD)

Links

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