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

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bracco Diagnostics, Inc

Criteria

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