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OpenTrials
Completed

NCT Number: NCT00309075

Magnevist® Injection Enhanced MRA Compared to Non Contrast MRA for the Detection of Stenosis in the Calf and/or Pedal Arteries

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.

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Key information

Conditions

Stenosis Constriction, Pathologic Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Has known or suspected disease of the calf and/or pedal arteries
  • 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 calf and/or foot arteries

Treatment and study plan

Gadopentetate dimeglumine (Magnevist)

Drug

Gadopentetate dimeglumine (Magnevist Injection), approximately 0.1mmol/kg body weight, single intravenous administration on the study day

Primary outcomes

  1. Accuracy, sensitivity, and specificity based on visual assessment of stenosis assesses by blinded reader

    Time frame: Image creation after injection - evaluation at blind read

Secondary outcomes

  1. Diagnostic confidence

    Time frame: At blinded and/or open label read of the images

  2. Accuracy, sensitivity, and specificity based on visual assessment of stenosis assesses by open label reader

    Time frame: At blinded and/or open label read of the images

  3. Location and matching of stenosis

    Time frame: At blinded and/or open label read of the images

  4. Image quality

    Time frame: At blinded and/or open label read of the images

  5. Image evaluability and presence of artefacts

    Time frame: At blinded and/or open label read of the images

  6. Ability to visualize arteries

    Time frame: At blinded and/or open label read of the images

  7. Exact categorization of stenosis

    Time frame: At blinded and/or open label read of the images

  8. Number of evaluable arteries

    Time frame: At blinded and/or open label read of the images

  9. Duration of 2D-TOF and MRA

    Time frame: At blinded and/or open label read of the images

  10. Artery appropriate for bypass

    Time frame: At blinded and/or open label read of the images

  11. Patient management

    Time frame: from baseline to 24 hours follow-up

  12. Safety

    Time frame: from baseline to 24 hours follow-up

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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.

Important dates

Study start
2003
Study completion
2004
First posted
Mar 31, 2006
Registry last updated
Dec 30, 2014

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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