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OpenTrials
Completed

NCT Number: NCT00185276

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

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.

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Key information

Conditions

Peripheral Vascular Disease Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

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 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

Treatment and study plan

Gadopentetate dimeglumine (Magnevist, BAY86-4882)

Drug

Single intravenous injection on the study day: lower dose corresponding approx. 0.1 mmol/kg body weight

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2003
Study completion
2004
First posted
Sep 16, 2005
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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