Trial Condition(s):
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
91463
Not Available
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.
- 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
- 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)
Locations | Status | |
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Locations Investigative Site Essen, Germany, 45122 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mainz, Germany, 55131 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Muenster, Germany, 48129 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Graz, Austria, 8036 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wien, Austria, 1020 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wien, Austria, 1090 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St Poelten, Austria, A-3100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Baden, Switzerland, 5404 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sao Paulo, Brazil, 05403-000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Curitiba, Brazil, 80060-900 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mexico, Mexico, 10700 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mexico D. F., Mexico, 06760 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Köln, Germany, 50924 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Berlin, Germany, 13353 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bonn, Germany, 53105 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Frankfurt, Germany, 60389 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Basel, Switzerland, 4031 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Buenos Aires, Argentina, C1082ACA | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Buenos Aires, Argentina | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Buenos Aires, Argentina, C1425BEE | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sao Paulo, Brazil, 05443000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sao Paulo, Brazil, 01323-001 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Rio de Janeiro, Brazil, 22649 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hamburg, Germany, 20246 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Frankfurt a. M., Germany, 60590 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hamburg, Germany, 20251 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Monterrey / Nuevo Leon, Mexico, 64460 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lornas de Zamora, Argentina, B1832BQS | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Diagnostic
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1