check_circleStudy Completed

Stenosis

Bayer Identifier:

91251

ClinicalTrials.gov Identifier:

NCT00309075

EudraCT Number:

Not Available

EU CT Number:

Not Available
Magnevist® Injection enhanced MRA compared to non contrast MRA for the detection of stenosis in the calf and/or pedal 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 calf and foot 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 disease of the calf and/or pedal arteries
    - 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 calf and/or foot arteries

Trial summary

Enrollment Goal
126
Trial Dates
December 2003 - November 2004
Phase
Phase 3
Could I Receive a placebo
No
Products
Magnevist (Gadopentetate Dimeglumine, BAY86-4882)
Accepts Healthy Volunteer
No

Primary Outcome

  • Accuracy, sensitivity, and specificity based on visual assessment of stenosis assesses by blinded reader
    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 and/or open label read of the images
    enhanced_encryption
    Safety Issue:
    None
  • Accuracy, sensitivity, and specificity based on visual assessment of stenosis assesses by open label reader
    date_rangeTime Frame:
    At blinded and/or open label read of the images
    enhanced_encryption
    Safety Issue:
    None
  • Location and matching of stenosis
    date_rangeTime Frame:
    At blinded and/or open label read of the images
    enhanced_encryption
    Safety Issue:
    None
  • Image quality
    date_rangeTime Frame:
    At blinded and/or open label read of the images
    enhanced_encryption
    Safety Issue:
    None
  • Image evaluability and presence of artefacts
    date_rangeTime Frame:
    At blinded and/or open label read of the images
    enhanced_encryption
    Safety Issue:
    None
  • Ability to visualize arteries
    date_rangeTime Frame:
    At blinded and/or open label read of the images
    enhanced_encryption
    Safety Issue:
    None
  • Exact categorization of stenosis
    date_rangeTime Frame:
    At blinded and/or open label read of the images
    enhanced_encryption
    Safety Issue:
    None
  • Number of evaluable arteries
    date_rangeTime Frame:
    At blinded and/or open label read of the images
    enhanced_encryption
    Safety Issue:
    None
  • Duration of 2D-TOF and MRA
    date_rangeTime Frame:
    At blinded and/or open label read of the images
    enhanced_encryption
    Safety Issue:
    None
  • Artery appropriate for bypass
    date_rangeTime Frame:
    At blinded and/or open label read of the 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

Multicenter, open-label study of the safety (open-label) and efficacy (open-label and blinded reader) of a single administration of approximately 0.1 mmol/kg of Magnevist® Injection-enhanced magnetic resonance arteriography (MRA) and 2-dimensional-time-of-flight (2D-TOF) MRA in patients with known or suspected disease of the calf and/or pedal arteries undergoing MRA of the calf and pedal arteries with intra-arterial digital subtraction arteriography (i.a. DSA) as the standard of reference.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Diagnostic
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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