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

Last updated: April 22, 2010
Sponsor: Bayer
Overall Status: Completed

Phase

3

Condition

Vascular Diseases

Circulation Disorders

Peripheral Arterial Occlusive Disease

Treatment

N/A

Clinical Study ID

NCT00296855
91463
EudraCT No. 2005-002547-66
308861
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 theinfrarenal 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 mentionedabove using a standard extracellular contrast agent performed within 1 - 7 days priorto the study MRA examination

Exclusion

Exclusion Criteria:

  • Less than 18 years of age

  • Women who are pregnant, breast feeding or who are of childbearing potential and havenot 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 threeangiographic 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 drugsand contrast agents or with a history of sickle cell disease or other hemolytic anemia

  • Having any contraindication to magnetic resonance imaging (MRI) examination orspecifically for MRA (e.g. pacemaker, recent wound clips, and severe claustrophobia)

Study Design

Total Participants: 261
Study Start date:
February 01, 2006
Estimated Completion Date:
February 28, 2007

Study 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.

Connect with a study center

  • Lornas de Zamora, Buenos Aires B1832BQS
    Argentina

    Site Not Available

  • Buenos Aires, Capital Federal C1082ACA
    Argentina

    Site Not Available

  • empty

    St. Pölten, Niederösterreich 3100
    Austria

    Site Not Available

  • St. Pölten, Niederösterreich 3100
    Austria

    Site Not Available

  • Graz, Steiermark 8036
    Austria

    Site Not Available

  • Wien, 1090
    Austria

    Site Not Available

  • Curitiba, Parana 80060-900
    Brazil

    Site Not Available

  • Rio de Janeiro, RJ 22649
    Brazil

    Site Not Available

  • Sao Paulo, SP 05403-900
    Brazil

    Site Not Available

  • empty

    São Paulo, SP 01323-001
    Brazil

    Site Not Available

  • São Paulo, SP 01323-001
    Brazil

    Site Not Available

  • Frankfurt, Hessen 60596
    Germany

    Site Not Available

  • Bonn, Nordrhein-Westfalen 53105
    Germany

    Site Not Available

  • Essen, Nordrhein-Westfalen 45147
    Germany

    Site Not Available

  • empty

    Köln, Nordrhein-Westfalen 50931
    Germany

    Site Not Available

  • Köln, Nordrhein-Westfalen 50931
    Germany

    Site Not Available

  • empty

    Münster, Nordrhein-Westfalen 48149
    Germany

    Site Not Available

  • Münster, Nordrhein-Westfalen 48149
    Germany

    Site Not Available

  • Mainz, Rheinland-Pfalz 55131
    Germany

    Site Not Available

  • Berlin, 13353
    Germany

    Site Not Available

  • Hamburg, 20251
    Germany

    Site Not Available

  • Monterrey, Nuevo León 64460
    Mexico

    Site Not Available

  • Mexico D. F., 06760
    Mexico

    Site Not Available

  • empty

    México D.F., 10700
    Mexico

    Site Not Available

  • México D.F., 10700
    Mexico

    Site Not Available

  • Baden, 5404
    Switzerland

    Site Not Available

  • Basel, 4031
    Switzerland

    Site Not Available

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