check_circleStudy Completed

Peripheral vascular disease

Bayer Identifier:

91208

ClinicalTrials.gov Identifier:

NCT00185276

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

Trial 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.

Key Participants Requirements

Sex

Both

Age

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

Trial summary

Enrollment Goal
365
Trial Dates
March 2003 - August 2004
Phase
Phase 3
Could I Receive a placebo
No
Products
Magnevist (Gadopentetate Dimeglumine, BAY86-4882)
Accepts Healthy Volunteer
No

Primary Outcome

  • Sensitivity, specificity and accuracy of the higher dose of Magnevist® Injection and 2D-TOF MRA for the detection of clinically significant disease
    date_rangeTime Frame:
    Image creation after injection - evaluation at blind read
    enhanced_encryption
    Safety Issue:
    None

Secondary Outcome

  • Diagnostic confidence
    date_rangeTime Frame:
    At blinded or/and open label read of images
    enhanced_encryption
    Safety Issue:
    None
  • Visual assessment of stenosis
    date_rangeTime Frame:
    At blinded or/and open label read of images
    enhanced_encryption
    Safety Issue:
    None
  • Difference in degree of stenosis
    date_rangeTime Frame:
    At blinded or/and open label read of images
    enhanced_encryption
    Safety Issue:
    None
  • Other diagnostic findings
    date_rangeTime Frame:
    At blinded or/and open label read of images
    enhanced_encryption
    Safety Issue:
    None
  • Image quality
    date_rangeTime Frame:
    At blinded or/and open label read of images
    enhanced_encryption
    Safety Issue:
    None
  • Image evaluability and presence of artifacts
    date_rangeTime Frame:
    At blinded or/and open label read of images
    enhanced_encryption
    Safety Issue:
    None
  • Ability to visualize arterial segments
    date_rangeTime Frame:
    At blinded or/and open label read of images
    enhanced_encryption
    Safety Issue:
    None
  • Number of evaluable segments
    date_rangeTime Frame:
    At blinded or/and open label read of images
    enhanced_encryption
    Safety Issue:
    None
  • Location and matching of stenosis
    date_rangeTime Frame:
    At blinded or/and open label read of images
    enhanced_encryption
    Safety Issue:
    None
  • SI measurements
    date_rangeTime Frame:
    At blinded or/and open label read of images
    enhanced_encryption
    Safety Issue:
    None
  • Patient management
    date_rangeTime Frame:
    From baseline to 24 hours follow-up
    enhanced_encryption
    Safety Issue:
    None
  • Safety
    date_rangeTime Frame:
    From baseline to 24 hours follow-up
    enhanced_encryption
    Safety Issue:
    None

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Diagnostic
Allocation
Randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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