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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

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ClinicalTrials.gov Identifier: NCT00185276
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : December 30, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Peripheral Vascular Disease Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882) Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 365 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2003
Study Completion Date : August 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. Diagnostic confidence [ Time Frame: At blinded or/and open label read of images ]
  2. Visual assessment of stenosis [ Time Frame: At blinded or/and open label read of images ]
  3. Difference in degree of stenosis [ Time Frame: At blinded or/and open label read of images ]
  4. Other diagnostic findings [ Time Frame: At blinded or/and open label read of images ]
  5. Image quality [ Time Frame: At blinded or/and open label read of images ]
  6. Image evaluability and presence of artifacts [ Time Frame: At blinded or/and open label read of images ]
  7. Ability to visualize arterial segments [ Time Frame: At blinded or/and open label read of images ]
  8. Number of evaluable segments [ Time Frame: At blinded or/and open label read of images ]
  9. Location and matching of stenosis [ Time Frame: At blinded or/and open label read of images ]
  10. SI measurements [ Time Frame: At blinded or/and open label read of images ]
  11. Patient management [ Time Frame: From baseline to 24 hours follow-up ]
  12. Safety [ Time Frame: From baseline to 24 hours follow-up ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00185276


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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00185276     History of Changes
Other Study ID Numbers: 91208
306781
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: December 30, 2014
Last Verified: December 2014

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