CompletedPhase 3

Magnevist® Injection Enhanced MRA at Two Dose Levels Compared to Non Contrast MRA for the Detection of Structural Abnormalities of the Infrarenal Aorta and Peripheral Arteries

365 participantsStarted 2003-03

Plain-language summary

The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Magnevist (the study drug) used for MRI of the infrarenal aorta and peripheral arteries. The results will be compared to the results of MRI taken without Magnevist, and with the results of your X-ray angiography.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Has known or suspected peripheral vascular disease * Is scheduled for X-ray angiography Exclusion Criteria: * Has any contraindication to magnetic resonance imaging * Is scheduled for any procedure before the X-ray angiography * Had previously had stents placed bilaterally in the region to be imaged

What they're measuring

Sensitivity, specificity and accuracy of the higher dose of Magnevist® Injection and 2D-TOF MRA for the detection of clinically significant disease

Timeframe: Image creation after injection - evaluation at blind read

Trial details

NCT IDNCT00185276

SponsorBayer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

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