Trial Condition(s):

Peripheral Vascular Diseases

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

Bayer Identifier:

91463

ClinicalTrials.gov Identifier:

NCT00296855

EudraCT Number:

2005-002547-66

EU CT Number:

Not Available

Study Completed

Trial Purpose

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.

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)

Trial Summary

Enrollment Goal
261
Trial Dates
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Phase
3
Could I receive a placebo?
No
Products
Ablavar (Gadofosveset Trisodium, BAY86-5283)
Accepts Healthy Volunteers
No

Where to Participate

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Investigative Site

Essen, Germany, 45122

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Mainz, Germany, 55131

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Muenster, Germany, 48129

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Graz, Austria, 8036

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Wien, Austria, 1020

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Wien, Austria, 1090

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St Poelten, Austria, A-3100

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Baden, Switzerland, 5404

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Sao Paulo, Brazil, 05403-000

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Curitiba, Brazil, 80060-900

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Mexico, Mexico, 10700

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Mexico D. F., Mexico, 06760

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Köln, Germany, 50924

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Berlin, Germany, 13353

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Bonn, Germany, 53105

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Frankfurt, Germany, 60389

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Basel, Switzerland, 4031

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Buenos Aires, Argentina, C1082ACA

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Buenos Aires, Argentina

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Buenos Aires, Argentina, C1425BEE

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Sao Paulo, Brazil, 05443000

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Sao Paulo, Brazil, 01323-001

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Rio de Janeiro, Brazil, 22649

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Hamburg, Germany, 20246

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Frankfurt a. M., Germany, 60590

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Hamburg, Germany, 20251

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Monterrey / Nuevo Leon, Mexico, 64460

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Lornas de Zamora, Argentina, B1832BQS

Trial Design