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
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00296855
First received: February 24, 2006
Last updated: April 22, 2010
Last verified: April 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Peripheral Vascular Diseases |
Drug: Vasovist (BAY86-5283, MS-325) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| 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 |
Resource links provided by NLM:
Further study details as provided by Bayer:
Primary Outcome Measures:
- Diagnostic potential of Vasovist enhanced MRA [ Time Frame: Imaging after baseline visit, before and after Vasovist injection ]
Secondary Outcome Measures:
- Comparison of the quantitative assessment and the qualitative assessment of arterial stenosis/disease as compared to X-ray angiography [ Time Frame: After imaging ]
- Quantitative assessment of vessel enhancement [ Time Frame: After imaging ]
- Qualitative assessment of disease [ Time Frame: After imaging ]
- Qualitative assessment of plaque morphology [ Time Frame: After imaging ]
- Evaluation of quality of vascular anatomy and delineation of vessel wall, venous enhancement and diagnostic potential of venous enhancement [ Time Frame: After imaging ]
| Enrollment: | 261 |
| Study Start Date: | February 2006 |
| Study Completion Date: | February 2007 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 |
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
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00296855
Locations
| Argentina | |
| Lornas de Zamora, Buenos Aires, Argentina, B1832BQS | |
| Buenos Aires, Capital Federal, Argentina, C1082ACA | |
| Buenos Aires, Capital Federal, Argentina, C1428DDO | |
| Buenos Aires, Argentina | |
| Austria | |
| St. Pölten, Niederösterreich, Austria, 3100 | |
| Graz, Steiermark, Austria, 8036 | |
| Wien, Austria, 1021 | |
| Wien, Austria, 1090 | |
| Brazil | |
| Curitiba, Parana, Brazil, 80060-900 | |
| Rio de Janeiro, RJ, Brazil, 22649 | |
| Sao Paulo, SP, Brazil, 05403-900 | |
| São Paulo, SP, Brazil, 01323-001 | |
| Germany | |
| Frankfurt, Hessen, Germany, 60596 | |
| Frankfurt, Hessen, Germany, 60389 | |
| Bonn, Nordrhein-Westfalen, Germany, 53105 | |
| Essen, Nordrhein-Westfalen, Germany, 45147 | |
| Köln, Nordrhein-Westfalen, Germany, 50931 | |
| Münster, Nordrhein-Westfalen, Germany, 48149 | |
| Mainz, Rheinland-Pfalz, Germany, 55131 | |
| Berlin, Germany, 13353 | |
| Hamburg, Germany, 20251 | |
| Mexico | |
| Monterrey, Nuevo León, Mexico, 64460 | |
| Mexico D. F., Mexico, 06760 | |
| México D.F., Mexico, 10700 | |
| Switzerland | |
| Baden, Switzerland, 5404 | |
| Basel, Switzerland, 4031 | |
Sponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Therapeutic Area Head, Bayer Schering Pharma AG |
| ClinicalTrials.gov Identifier: | NCT00296855 History of Changes |
| Other Study ID Numbers: | 91463, EudraCT No. 2005-002547-66, 308861 |
| Study First Received: | February 24, 2006 |
| Last Updated: | April 22, 2010 |
| Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Austria: Ministry of Labor, Health and Social Affairs Brazil: National Health Surveillance Agency Mexico: Federal Commission for Sanitary Risks Protection Germany: Federal Institute for Drugs and Medical Devices Switzerland: Swissmedic |
Keywords provided by Bayer:
|
Peripheral artery disease |
Additional relevant MeSH terms:
|
Vascular Diseases Peripheral Vascular Diseases Peripheral Arterial Disease Cardiovascular Diseases |
Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases |
ClinicalTrials.gov processed this record on June 17, 2013