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

Bayer

Status and phase

Completed

Phase 3

Conditions

Peripheral Vascular Diseases

Treatments

Drug: Vasovist (BAY86-5283, MS-325)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00296855

308861

EudraCT No. 2005-002547-66

91463

Details and patient eligibility

About

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.

Full 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.

Enrollment

261 patients

Sex

All

Ages

18+ years old

Volunteers

No 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)