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Efficacy evaluation of DOTAREM®-enhanced MRA compared to GADOVIST®–enhanced MRA in the diagnosis of clinically significant abdominal or lower limb arterial diseases

Mise à jour : Il y a 4 ans
Référence : EUCTR2009-010968-42

Femme et Homme

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Extrait

To demonstrate the clinical equivalence (statistical non-inferiority) in terms of global diagnostic performance of DOTAREM®-enhanced MRA as compared to GADOVIST® - enhanced MRA by comparing the degree of agreement at the patient level of each MRA method when using X-Ray Angiography (DSA) as a gold standard.

Critère d'inclusion

  • Patient suffering from abdominal or lower limb arterial diseases

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