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

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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Locations
Status
LocationsStatus
Locations

Investigative Site

Essen, Germany, 45122

Status
Completed
 
Locations

Investigative Site

Mainz, Germany, 55131

Status
Completed
 
Locations

Investigative Site

Muenster, Germany, 48129

Status
Terminated
 
Locations

Investigative Site

Graz, Austria, 8036

Status
Completed
 
Locations

Investigative Site

Wien, Austria, 1020

Status
Completed
 
Locations

Investigative Site

Wien, Austria, 1090

Status
Terminated
 
Locations

Investigative Site

St Poelten, Austria, A-3100

Status
Completed
 
Locations

Investigative Site

Baden, Switzerland, 5404

Status
Completed
 
Locations

Investigative Site

Sao Paulo, Brazil, 05403-000

Status
Completed
 
Locations

Investigative Site

Curitiba, Brazil, 80060-900

Status
Completed
 
Locations

Investigative Site

Mexico, Mexico, 10700

Status
Terminated
 
Locations

Investigative Site

Mexico D. F., Mexico, 06760

Status
Completed
 
Locations

Investigative Site

Köln, Germany, 50924

Status
Terminated
 
Locations

Investigative Site

Berlin, Germany, 13353

Status
Completed
 
Locations

Investigative Site

Bonn, Germany, 53105

Status
Completed
 
Locations

Investigative Site

Frankfurt, Germany, 60389

Status
Completed
 
Locations

Investigative Site

Basel, Switzerland, 4031

Status
Completed
 
Locations

Investigative Site

Buenos Aires, Argentina, C1082ACA

Status
Completed
 
Locations

Investigative Site

Buenos Aires, Argentina

Status
Completed
 
Locations

Investigative Site

Buenos Aires, Argentina, C1425BEE

Status
Completed
 
Locations

Investigative Site

Sao Paulo, Brazil, 05443000

Status
Completed
 
Locations

Investigative Site

Sao Paulo, Brazil, 01323-001

Status
Terminated
 
Locations

Investigative Site

Rio de Janeiro, Brazil, 22649

Status
Terminated
 
Locations

Investigative Site

Hamburg, Germany, 20246

Status
Completed
 
Locations

Investigative Site

Frankfurt a. M., Germany, 60590

Status
Completed
 
Locations

Investigative Site

Hamburg, Germany, 20251

Status
Completed
 
Locations

Investigative Site

Monterrey / Nuevo Leon, Mexico, 64460

Status
Completed
 
Locations

Investigative Site

Lornas de Zamora, Argentina, B1832BQS

Status
Completed
 

Trial Design