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

Phase 3

Completed

• Conditions: Peripheral Vascular Diseases
• Interventions: Drug: Vasovist (BAY86-5283, MS-325)

• Registration Number: NCT00296855
• Lead Sponsor: Bayer

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-02-24
• Study First Submitted QC: 2006-02-24
• Study First Posted: 2006-02-27
• Study Completion: 2007-02
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-22
• Last Update Posted: 2010-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 261

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Vasovist (BAY86-5283, MS-325)	-

Primary Outcome Measures

Name	Time	Method
Diagnostic potential of Vasovist enhanced MRA	Imaging after baseline visit, before and after Vasovist injection

Secondary Outcome Measures

Name	Time	Method
Quantitative assessment of vessel enhancement	After imaging
Qualitative assessment of plaque morphology	After imaging
Comparison of the quantitative assessment and the qualitative assessment of arterial stenosis/disease as compared to X-ray angiography	After imaging
Qualitative assessment of disease	After imaging
Evaluation of quality of vascular anatomy and delineation of vessel wall, venous enhancement and diagnostic potential of venous enhancement	After imaging