check_circleStudy 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
  • - 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
  • - 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
No
Products
Ablavar (Gadofosveset Trisodium, BAY86-5283)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
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
    date_rangeTime Frame:
    Imaging after baseline visit, before and after Vasovist injection
    enhanced_encryption
    Safety Issue:
    None

Secondary Outcome

  • Comparison of the quantitative assessment and the qualitative assessment of arterial stenosis/disease as compared to X-ray angiography
    date_rangeTime Frame:
    After imaging
    enhanced_encryption
    Safety Issue:
    None
  • Quantitative assessment of vessel enhancement
    date_rangeTime Frame:
    After imaging
    enhanced_encryption
    Safety Issue:
    None
  • Qualitative assessment of disease
    date_rangeTime Frame:
    After imaging
    enhanced_encryption
    Safety Issue:
    None
  • Qualitative assessment of plaque morphology
    date_rangeTime Frame:
    After imaging
    enhanced_encryption
    Safety Issue:
    None
  • Evaluation of quality of vascular anatomy and delineation of vessel wall, venous enhancement and diagnostic potential of venous enhancement
    date_rangeTime Frame:
    After imaging
    enhanced_encryption
    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
1

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to marketed products.