This study aims at investigating the diagnostic accuracy of magnetic resonance angiography using the contrast agent Vasovist® in the detection of relevant vascular narrowing of the lower extremity. Patients who have been scheduled for intra-arterial conventional angiography are eligible for this trial.
Patients will only be included into the study if either MRA with extracellular contrast agents, computed tomography angiography, ultrasound or i.a. DSA have been performed beforehand and if the patient has been scheduled for an i.a. DSA to be performed. Vasovist® enhanced MRA imaging will be performed using a state-of-the-art 1.5T MR system. Recruitment, baseline examinations, Vasovist®-enhanced MRA of the vessel segments of interest and follow-up examinations will be performed in up to 8 radiological clinics in Europe. The safety follow-up period will be at least 12 hours but not more than 24 hours post injection of Vasovist® and includes the assessment of physical examinations and vital signs as well as the assessment of AEs. DSA must be carried out at least 12 hours after Vasovist® administration and only after the last follow-up visit has been performed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
150
Single MR-Angiography of the lower extremity after the bolus injection 0.03mmol/kg BW Vasovist
University Medical Center Mannheim
Mannheim, Germany
University of Munich
Munich, Germany
Accuracy of quantitative stenosis grading (<50%, >=50%) of Vasovist enhanced MRA with regard to i.a. DSA as standard of reference
Time frame: End of study (anticipated Sep 2009)
Proportion of correct stenosis gradings (<50%, 50-99%, occlusion) of Vasovist® enhanced MRA compared to DSA
Time frame: End of study
Sensitivity and specificity (<50%, >=50%) of Vasovist enhanced MRA compared to DSA
Time frame: End of study
Length of stenosis (target) of Vasovist® enhanced MRA compared to DSA
Time frame: End of study
Correlation of the description of the inflow, target, outflow of Vasovist® enhanced MRA (combined) compared to DSA
Time frame: End of study
Diagnostic value (detection of target lesion y/n) of time-resolved first pass MRA in comparison to high-spatial resolution steady state MRA
Time frame: End of study
Additional venous pathologies
Time frame: End of study
Diagnostic confidence of Vasovist enhanced MRA and DSA
Time frame: End of study
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