Study Completed

Peripheral vascular diseases

Bayer Identifier:

91463

ClinicalTrials.gov Identifier:

NCT00296855

EudraCT Number:

2005-002547-66

EU CT Number:

Not Available

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

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.

Key Participants Requirements

Sex

Both

Age

18 Years

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

February 2006 - February 2007

Phase

Phase 3

Could I Receive a placebo

Products

Ablavar (Gadofosveset Trisodium, BAY86-5283)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Essen, 45122, Germany
Completed		Mainz, 55131, Germany
Terminated		Muenster, 48129, Germany
Completed		Graz, 8036, Austria
Completed		Wien, 1020, Austria
Terminated		Wien, 1090, Austria
Completed		St Poelten, A-3100, Austria
Completed		Baden, 5404, Switzerland
Completed		Sao Paulo, 05403-000, Brazil
Completed		Curitiba, 80060-900, Brazil
Terminated		Mexico, 10700, Mexico
Completed		Mexico D. F., 06760, Mexico
Terminated		Köln, 50924, Germany
Completed		Berlin, 13353, Germany
Completed		Bonn, 53105, Germany
Completed		Frankfurt, 60389, Germany
Completed		Basel, 4031, Switzerland
Completed		Buenos Aires, C1082ACA, Argentina
Completed		Buenos Aires, Argentina
Completed		Buenos Aires, C1425BEE, Argentina
Completed		Sao Paulo, 05443000, Brazil
Terminated		Sao Paulo, 01323-001, Brazil
Terminated		Rio de Janeiro, 22649, Brazil
Completed		Hamburg, 20246, Germany
Completed		Frankfurt a. M., 60590, Germany
Completed		Hamburg, 20251, Germany
Completed		Monterrey / Nuevo Leon, 64460, Mexico
Completed		Lornas de Zamora, B1832BQS, Argentina

Primary Outcome

Diagnostic potential of Vasovist enhanced MRA
Time Frame:
Imaging after baseline visit, before and after Vasovist injection
Safety Issue:
None

Secondary Outcome

Comparison of the quantitative assessment and the qualitative assessment of arterial stenosis/disease as compared to X-ray angiography
Time Frame:
After imaging
Safety Issue:
None
Quantitative assessment of vessel enhancement
Time Frame:
After imaging
Safety Issue:
None
Qualitative assessment of disease
Time Frame:
After imaging
Safety Issue:
None
Qualitative assessment of plaque morphology
Time Frame:
After imaging
Safety Issue:
None
Evaluation of quality of vascular anatomy and delineation of vessel wall, venous enhancement and diagnostic potential of venous enhancement
Time Frame:
After imaging
Safety Issue:
None

Trial design

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

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Diagnostic

Allocation

Non-randomized

Blinding

Open Label

Assignment

Single Group Assignment

Trial Arms

Additional Information

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