Carotid, Aortic, Renal or Peripheral Artery Disease Clinical Trial
— VALUEOfficial title:
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
| Verified date | January 2012 |
| Source | Bracco Diagnostics, Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | China: Food and Drug Administration |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 120 |
| Est. completion date | December 2011 |
| Est. primary completion date | December 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| China | Radiology Department Zhongshan Hospital, Fudan University | Shanghai |
| Lead Sponsor | Collaborator |
|---|---|
| Bracco Diagnostics, Inc |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Diagnostic Preference | Comparison of a single dose of MultiHance versus the double dose of Magnevist currently used for MR Angiography of the carotid, renal/abdominal/ and peripheral arteries in terms of global diagnostic perference | Immediately post dose | No |
| Secondary | Safety comparison of two diagnostic agents | to compare the safety of the two investigational products in patients undergoing CE-MRA of the carotid, renal/abdominal and peripheral arteries | UP to 24 hours post dose of each contrast agent | No |