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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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00296855
First received: February 24, 2006
Last updated: April 22, 2010
Last verified: April 2010
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, 60389
Frankfurt, Hessen, Germany, 60596
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:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Contrast Media
Gadofosveset trisodium
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2014