Comparison Study of Vasovist® Magnetic Resonance Angiography (MRA) and an MRA With a Conventional Extracellular Contrast Agent With X-ray Angiography in Patients With Peripheral Artery Disease

April 22, 2010 updated by: Bayer

Intra-individual Open-label Multicenter Comparison Study of Magnetic Resonance Angiography (MRA) With the Blood Pool Contrast Agent Vasovist® and a Conventional Extracellular Contrast Agent With Intra-arterial Digital Subtraction Angiography (i.a. DSA) in Patients With Peripheral Artery Disease

The particular aim of this study is the comparison of the diagnostic results of MRA images upon application of Vasovist (gadofosveset), a contrast agent not yet available on the market, with the MRA images upon application of a conventional extracellular contrast agent. A catheter angiography, which will be performed as a routine diagnostic procedure for vascular diseases, will serve as an evaluation standard.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Study Type

Interventional

Enrollment (Actual)

261

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
    • Buenos Aires
      • Lornas de Zamora, Buenos Aires, Argentina, B1832BQS
    • Capital Federal
      • Buenos Aires, Capital Federal, Argentina, C1082ACA
      • Buenos Aires, Capital Federal, Argentina, C1428DDO
  • Austria
      • Wien, Austria, 1090
      • Wien, Austria, 1021
    • Niederösterreich
      • St. Pölten, Niederösterreich, Austria, 3100
    • Steiermark
      • Graz, Steiermark, Austria, 8036
  • Brazil
    • Parana
      • Curitiba, Parana, Brazil, 80060-900
    • RJ
      • Rio de Janeiro, RJ, Brazil, 22649
    • SP
      • Sao Paulo, SP, Brazil, 05403-900
      • São Paulo, SP, Brazil, 01323-001
  • Germany
      • Berlin, Germany, 13353
      • Hamburg, Germany, 20251
    • Hessen
      • Frankfurt, Hessen, Germany, 60596
      • Frankfurt, Hessen, Germany, 60389
    • Nordrhein-Westfalen
      • Bonn, Nordrhein-Westfalen, Germany, 53105
      • Essen, Nordrhein-Westfalen, Germany, 45147
      • Köln, Nordrhein-Westfalen, Germany, 50931
      • Münster, Nordrhein-Westfalen, Germany, 48149
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany, 55131
  • Mexico
      • Mexico D. F., Mexico, 06760
      • México D.F., Mexico, 10700
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
  • Switzerland
      • Baden, Switzerland, 5404
      • Basel, Switzerland, 4031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with a certain circulation disorder (aortoiliac disease Fontaine-stage IIb / IV) and an indication for the evaluation of the peripheral run-off arteries from the infrarenal aorta to the calves
  • Patients who are scheduled for X-ray angiography and magnetic resonance angiography (MRA) of the arteries mentioned above
  • Patients who have had a contrast-enhanced MRA examination of the arteries mentioned above using a standard extracellular contrast agent performed within 1 - 7 days prior to the study MRA examination

Exclusion Criteria:

  • Less than 18 years of age
  • Women who are pregnant, breast feeding or who are of childbearing potential and have not had a negative urine pregnancy test the same day as the study MRA examination
  • Requiring immediate therapy for their vascular disease or in whom conduct of all three angiographic procedures is not possible
  • Not being able to remain lying down for at least 45 - 60 min
  • Patients with a history of serious allergic reactions to any allergen including drugs and contrast agents or with a history of sickle cell disease or other hemolytic anemia
  • Having any contraindication to magnetic resonance imaging (MRI) examination or specifically for MRA (e.g. pacemaker, recent wound clips, and severe claustrophobia)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Drug: Vasovist (BAY86-5283, MS-325)
All patients receive a single IV bolus injection of Vasovist at a dose of 0,03 mmol/kg BW at a flowrate of 0,5 mL/sec, followed by a saline flush of at least 30 mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diagnostic potential of Vasovist enhanced MRA
Time Frame: Imaging after baseline visit, before and after Vasovist injection
Imaging after baseline visit, before and after Vasovist injection

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison of the quantitative assessment and the qualitative assessment of arterial stenosis/disease as compared to X-ray angiography
Time Frame: After imaging
After imaging
Quantitative assessment of vessel enhancement
Time Frame: After imaging
After imaging
Qualitative assessment of disease
Time Frame: After imaging
After imaging
Qualitative assessment of plaque morphology
Time Frame: After imaging
After imaging
Evaluation of quality of vascular anatomy and delineation of vessel wall, venous enhancement and diagnostic potential of venous enhancement
Time Frame: After imaging
After imaging

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

February 24, 2006

First Submitted That Met QC Criteria

February 24, 2006

First Posted (Estimate)

February 27, 2006

Study Record Updates

Last Update Posted (Estimate)

April 23, 2010

Last Update Submitted That Met QC Criteria

April 22, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 91463
  • EudraCT No. 2005-002547-66
  • 308861

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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