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

Bracco

Status and phase

Completed

Phase 3

Conditions

Carotid, Aortic, Renal or Peripheral Artery Disease

Treatments

Drug: Gadobenate Dimeglumine

Drug: Gadopentetate Dimeglumine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01260636

MH-137

Details and patient eligibility

About

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

Enrollment

120 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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