Woman and Man
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Extract
The primary objective of this study is to evaluate the efficacy of gadobutrol-enhanced MRA over 2D-ToF MRA in subjects with known or suspected renal artery disease, as verified by - superiority for structural delineation, - non-inferiority for the detection of clinically significant vascular disease, - non-inferiority for the exclusion of clinically significant vascular disease, - minimum performance for gadobutrol detection of clinically significant vascular disease, and - minimum performance for gadobutrol exclusion of clinically significant vascular disease using CTA as the SoR excluding the first objective, structural delineation.
Inclusion criteria
- Subjects with known or suspected renal artery disease