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Magnevist® Injection Enhanced MRA at Two Dose Levels Compared to Non Contrast MRA for the Detection of Structural Abnormalities of the Infrarenal Aorta and Peripheral Arteries

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00185276
First received: September 10, 2005
Last updated: July 7, 2009
Last verified: July 2009
History of Changes
  Purpose

The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Magnevist (the study drug) used for MRI of the infrarenal aorta and peripheral arteries. The results will be compared to the results of MRI taken without Magnevist, and with the results of your X-ray angiography.


Condition Intervention Phase
Peripheral Vascular Disease
 Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Randomized, Multi-Center Open Label Study of the Safety (Open-Label) and Efficacy (Open-Label & Blinded Reader) of Magnevist® Injection-Enhanced Magnetic Resonance Arteriography (MRA) at Two Dose Levels and 2-Dimensional-Time-of-Flight (2D-TOF) MRA in Patients Undergoing MRA of the Infrarenal Aorta and Peripheral Arteries With Intra-Arterial Digital Subtraction Arteriography (i.a. DSA) as Standard of Reference

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Sensitivity, specificity and accuracy of the higher dose of Magnevist® Injection and 2D-TOF MRA for the detection of clinically significant disease [ Time Frame: Image creation after injection - evaluation at blind read ]

Secondary Outcome Measures:
  • Diagnostic confidence [ Time Frame: At blinded or/and open label read of images ]
  • Visual assessment of stenosis [ Time Frame: At blinded or/and open label read of images ]
  • Difference in degree of stenosis [ Time Frame: At blinded or/and open label read of images ]
  • Other diagnostic findings [ Time Frame: At blinded or/and open label read of images ]
  • Image quality [ Time Frame: At blinded or/and open label read of images ]
  • Image evaluability and presence of artifacts [ Time Frame: At blinded or/and open label read of images ]
  • Ability to visualize arterial segments [ Time Frame: At blinded or/and open label read of images ]
  • Number of evaluable segments [ Time Frame: At blinded or/and open label read of images ]
  • Location and matching of stenosis [ Time Frame: At blinded or/and open label read of images ]
  • SI measurements [ Time Frame: At blinded or/and open label read of images ]
  • Patient management [ Time Frame: From baseline to 24 hours follow-up ]
  • Safety [ Time Frame: From baseline to 24 hours follow-up ]

Enrollment: 369
Study Start Date: March 2003
Study Completion Date: August 2004
Arms Assigned Interventions
Experimental: Arm 1 Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)
Single intravenous injection on the study day: lower dose corresponding approx. 0.1 mmol/kg body weight
Experimental: Arm 2 Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)
Single intravenous injection on the study day: higher dose corresponding approx. 0.2 - 0.3 mmol/kg body weight

Detailed Description:

This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.

Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has known or suspected peripheral vascular disease
  • Is scheduled for X-ray angiography

Exclusion Criteria:

  • Has any contraindication to magnetic resonance imaging
  • Is scheduled for any procedure before the X-ray angiography
  • Had previously had stents placed bilaterally in the region to be imaged
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00185276

Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00185276     History of Changes
Other Study ID Numbers: 91208, 306781
Study First Received: September 10, 2005
Last Updated: July 7, 2009
Health Authority: United States: Food and Drug Administration
Argentina: Ministry of Health

Keywords provided by Bayer:
Structural abnormalities of the infrarenal aorta and peripheral arteries

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
 Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on May 19, 2013