Clinical trial NCT00309075: Magnevist® Injection Enhanced MRA Compared to Non Contrast MRA for the Detection of Stenosis in the Calf and/or Pedal Arteries
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stenosis
Keywords: Stenosis of the calf and/or pedal arteries
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2006-03-31
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Accuracy, sensitivity, and specificity based on visual assessment of stenosis assesses by blinded reader
timeFrame: Image creation after injection - evaluation at blind read
Secondary outcomes:
measure: Diagnostic confidence
timeFrame: At blinded and/or open label read of the images
measure: Accuracy, sensitivity, and specificity based on visual assessment of stenosis assesses by open label reader
timeFrame: At blinded and/or open label read of the images
measure: Location and matching of stenosis
timeFrame: At blinded and/or open label read of the images
measure: Image quality
timeFrame: At blinded and/or open label read of the images
measure: Image evaluability and presence of artefacts
timeFrame: At blinded and/or open label read of the images
measure: Ability to visualize arteries
timeFrame: At blinded and/or open label read of the images
measure: Exact categorization of stenosis
timeFrame: At blinded and/or open label read of the images
measure: Number of evaluable arteries
timeFrame: At blinded and/or open label read of the images
measure: Duration of 2D-TOF and MRA
timeFrame: At blinded and/or open label read of the images
measure: Artery appropriate for bypass
timeFrame: At blinded and/or open label read of the images
measure: Patient management
timeFrame: from baseline to 24 hours follow-up
measure: Safety
timeFrame: from baseline to 24 hours follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: