Status:
COMPLETED
Crossover Comparison of Two Gadolinium Contrast Agents for Use With MRA of Carotid, Renal and Peripheral Arteries
Lead Sponsor:
Bracco Diagnostics, Inc
Conditions:
Carotid, Aortic, Renal or Peripheral Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01260636
Start Date
September 1 2009
End Date
December 1 2011
Last Update
January 5 2012
Active Locations (1)
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1
Radiology Department Zhongshan Hospital, Fudan University
Shanghai, China