Clinical trial NCT00296855: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Peripheral Vascular Diseases
Keywords: Peripheral artery disease
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2006-02-27
Enrollment: 261
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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)

Primary outcomes:
measure: Diagnostic potential of Vasovist enhanced MRA
timeFrame: Imaging after baseline visit, before and after Vasovist injection
Secondary outcomes:
measure: Comparison of the quantitative assessment and the qualitative assessment of arterial stenosis/disease as compared to X-ray angiography
timeFrame: After imaging
measure: Quantitative assessment of vessel enhancement
timeFrame: After imaging
measure: Qualitative assessment of disease
timeFrame: After imaging
measure: Qualitative assessment of plaque morphology
timeFrame: After imaging
measure: Evaluation of quality of vascular anatomy and delineation of vessel wall, venous enhancement and diagnostic potential of venous enhancement
timeFrame: After imaging
Other outcomes:
Locations:
city: Lornas de Zamora
country: Argentina
state: Buenos Aires
city: Buenos Aires
country: Argentina
state: Capital Federal
city: Buenos Aires
country: Argentina
state: Capital Federal
city: Buenos Aires
country: Argentina
city: St. Pölten
country: Austria
state: Niederösterreich
city: Graz
country: Austria
state: Steiermark
city: Wien
country: Austria
city: Wien
country: Austria
city: Curitiba
country: Brazil
state: Parana
city: Rio de Janeiro
country: Brazil
state: RJ
city: Sao Paulo
country: Brazil
state: SP
city: São Paulo
country: Brazil
state: SP
city: Frankfurt
country: Germany
state: Hessen
city: Frankfurt
country: Germany
state: Hessen
city: Bonn
country: Germany
state: Nordrhein-Westfalen
city: Essen
country: Germany
state: Nordrhein-Westfalen
city: Köln
country: Germany
state: Nordrhein-Westfalen
city: Münster
country: Germany
state: Nordrhein-Westfalen
city: Mainz
country: Germany
state: Rheinland-Pfalz
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Monterrey
country: Mexico
state: Nuevo León
city: Mexico D. F.
country: Mexico
city: México D.F.
country: Mexico
city: Baden
country: Switzerland
city: Basel
country: Switzerland
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: