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OpenTrials
Completed

NCT Number: NCT01260636

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

Completed

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Key information

Conditions

Carotid, Aortic, Renal or Peripheral Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Radiology Department Zhongshan Hospital, Fudan University

Shanghai, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gadobenate dimeglumine

Drug

0.1 mmol/kg, single dose

Other names: MultiHance

Gadopentetate Dimeglumine

Drug

Double dose of 0.2 mmol/kg

Other names: Magnevist

Primary outcomes

  1. Diagnostic Preference

    Time frame: Immediately post dose

    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

Secondary outcomes

  1. Safety comparison of two diagnostic agents

    Time frame: UP to 24 hours post dose of each contrast agent

    to compare the safety of the two investigational products in patients undergoing CE-MRA of the carotid, renal/abdominal and peripheral arteries

Sponsors and collaborators

Lead sponsor

Bracco Diagnostics, Inc

Industry

Registry information

Official study 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

Acronym: VALUE

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Dec 15, 2010
Registry last updated
Jan 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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