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
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.
Status | Completed |
Enrollment | 261 |
Est. completion date | February 2007 |
Est. primary completion date | |
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) |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bayer |
Argentina, Austria, Brazil, Germany, Mexico, Switzerland,
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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