Crossover Comparison of Two Gadolinium Contrast Agents for Use With MRA of Carotid, Renal and Peripheral Arteries

A Phase III, Comparative Multi-center Randomized Double-blind, Crossover Study of the Safety, Tolerability and Diagnostic Efficacy of Gadobenate Dimeglumine and Gadopentetate Dimeglumine in Magnetic Resonance Angiography of the Carotid, Renal/Abdominal and Peripheral Arteries

To compare two gadolinium contrast agents in terms of global paired diagnostic preference (primary endpoint) for the assessment of contrast-enhanced MR Angiography of the carotid, renal/abdominal and peripheral arteries

Inclusion Criteria:

• 18 yrs of age or older
• referred for enhanced MRA of carotid, renal/abdominal or peripheral arteries
• Able to provide written informed consent and comply with protocol requirements
• Highly suspected of or with known disease of the carotid, renal/abdominal or peripheral vasculature using specific criteria listed in the protocol

Exclusion Criteria:

• pregnant or lactating females
• Known allergy to one or more of the ingredients in the products under investigation
• Significant congestive heart failure ( Class IV)
• Moderate to severe chronic kidney disease
• Therapeutic intervention of any kind for vascular disease in the territory of interest between the two contrast procedures
• Vascular stents in vessels of interest
• Received another contrast agent in the 24 hrs preceding or proceeding each exam
• Previously entered into the study
• Contraindications to MRI
• Severe Claustrophobia Undergone DSA between the two exams