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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

Primary Purpose

Peripheral Vascular Diseases

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Vasovist (BAY86-5283, MS-325)
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Peripheral Vascular Diseases focused on measuring Peripheral artery disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Outcomes

Primary Outcome Measures

Diagnostic potential of Vasovist enhanced MRA

Secondary Outcome Measures

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

Full Information

First Posted
February 24, 2006
Last Updated
April 22, 2010
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00296855
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bayer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Vascular Diseases
Keywords
Peripheral artery disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
261 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Vasovist (BAY86-5283, MS-325)
Intervention Description
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
Primary Outcome Measure Information:
Title
Diagnostic potential of Vasovist enhanced MRA
Time Frame
Imaging after baseline visit, before and after Vasovist injection
Secondary Outcome Measure Information:
Title
Comparison of the quantitative assessment and the qualitative assessment of arterial stenosis/disease as compared to X-ray angiography
Time Frame
After imaging
Title
Quantitative assessment of vessel enhancement
Time Frame
After imaging
Title
Qualitative assessment of disease
Time Frame
After imaging
Title
Qualitative assessment of plaque morphology
Time Frame
After imaging
Title
Evaluation of quality of vascular anatomy and delineation of vessel wall, venous enhancement and diagnostic potential of venous enhancement
Time Frame
After imaging

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Lornas de Zamora
State/Province
Buenos Aires
ZIP/Postal Code
B1832BQS
Country
Argentina
City
Buenos Aires
State/Province
Capital Federal
ZIP/Postal Code
C1082ACA
Country
Argentina
City
Buenos Aires
State/Province
Capital Federal
ZIP/Postal Code
C1428DDO
Country
Argentina
City
Buenos Aires
Country
Argentina
City
St. Pölten
State/Province
Niederösterreich
ZIP/Postal Code
3100
Country
Austria
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8036
Country
Austria
City
Wien
ZIP/Postal Code
1021
Country
Austria
City
Wien
ZIP/Postal Code
1090
Country
Austria
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80060-900
Country
Brazil
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
22649
Country
Brazil
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-900
Country
Brazil
City
São Paulo
State/Province
SP
ZIP/Postal Code
01323-001
Country
Brazil
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60389
Country
Germany
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60596
Country
Germany
City
Bonn
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
53105
Country
Germany
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45147
Country
Germany
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50931
Country
Germany
City
Münster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48149
Country
Germany
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
City
Berlin
ZIP/Postal Code
13353
Country
Germany
City
Hamburg
ZIP/Postal Code
20251
Country
Germany
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64460
Country
Mexico
City
Mexico D. F.
ZIP/Postal Code
06760
Country
Mexico
City
México D.F.
ZIP/Postal Code
10700
Country
Mexico
City
Baden
ZIP/Postal Code
5404
Country
Switzerland
City
Basel
ZIP/Postal Code
4031
Country
Switzerland

12. IPD Sharing Statement

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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

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