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

Peripheral Vascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00296855
• Other study ID #: 91463
• Secondary ID: EudraCT No. 2005
• Status: Completed
• Phase: Phase 3
• First received: February 24, 2006
• Last updated: April 22, 2010
• Start date: February 2006
• Est. completion date: February 2007

Study information

• Verified date: April 2010
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaAustria: Ministry of Labor, Health and Social AffairsBrazil: National Health Surveillance AgencyMexico: Federal Commission for Sanitary Risks ProtectionGermany: Federal Institute for Drugs and Medical DevicesSwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 261
• Est. completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Drug:
• Vasovist (BAY86-5283, MS-325)
All patients receive a single IV bolus injection of Vasovist at a dose of 0,03 mmol/kg BW at a flowrate of 0,5 mL/sec, followed by a saline flush of at least 30 mL

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Argentina,  Austria,  Brazil,  Germany,  Mexico,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic potential of Vasovist enhanced MRA		Imaging after baseline visit, before and after Vasovist injection
Secondary	Comparison of the quantitative assessment and the qualitative assessment of arterial stenosis/disease as compared to X-ray angiography		After imaging
Secondary	Quantitative assessment of vessel enhancement		After imaging
Secondary	Qualitative assessment of disease		After imaging
Secondary	Qualitative assessment of plaque morphology		After imaging
Secondary	Evaluation of quality of vascular anatomy and delineation of vessel wall, venous enhancement and diagnostic potential of venous enhancement		After imaging

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