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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00309075
First received: March 30, 2006
Last updated: October 10, 2013
Last verified: October 2013
  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.


Condition Intervention Phase
Stenosis
Drug: Gadopentetate dimeglumine (Magnevist)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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.

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Diagnostic confidence [ Time Frame: At blinded and/or open label read of the images ]
  • 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 ]
  • Location and matching of stenosis [ Time Frame: At blinded and/or open label read of the images ]
  • Image quality [ Time Frame: At blinded and/or open label read of the images ]
  • Image evaluability and presence of artefacts [ Time Frame: At blinded and/or open label read of the images ]
  • Ability to visualize arteries [ Time Frame: At blinded and/or open label read of the images ]
  • Exact categorization of stenosis [ Time Frame: At blinded and/or open label read of the images ]
  • Number of evaluable arteries [ Time Frame: At blinded and/or open label read of the images ]
  • Duration of 2D-TOF and MRA [ Time Frame: At blinded and/or open label read of the images ]
  • Artery appropriate for bypass [ Time Frame: At blinded and/or open label read of the images ]
  • Patient management [ Time Frame: from baseline to 24 hours follow-up ]
  • Safety [ Time Frame: from baseline to 24 hours follow-up ]

Enrollment: 127
Study Start Date: December 2003
Study Completion Date: November 2004
Arms Assigned Interventions
Experimental: Arm 1 Drug: Gadopentetate dimeglumine (Magnevist)
Gadopentetate dimeglumine (Magnevist Injection), approximately 0.1mmol/kg body weight, single intravenous administration on the study day

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00309075

Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00309075     History of Changes
Other Study ID Numbers: 91251, 307260
Study First Received: March 30, 2006
Last Updated: October 10, 2013
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Brazil: Ministry of Health
Canada: Health Canada
Chile: Ministry of Health (ISP)
Mexico: Ministry of Health

Keywords provided by Bayer:
Stenosis of the calf and/or pedal arteries

Additional relevant MeSH terms:
Constriction, Pathologic
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 24, 2014