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Vasovist Magnetic Resonance Angiography (MRA) in Peripheral Arterial Occlusive Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00717639
Recruitment Status : Terminated (Required contrast media (Vasovist) withdrawn from market)
First Posted : July 17, 2008
Last Update Posted : August 8, 2011
Information provided by:
Heidelberg University

Tracking Information
First Submitted Date  ICMJE June 30, 2008
First Posted Date  ICMJE July 17, 2008
Last Update Posted Date August 8, 2011
Study Start Date  ICMJE May 2008
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2008)
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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Vasovist Magnetic Resonance Angiography (MRA) in Peripheral Arterial Occlusive Disease
Official Title  ICMJE Determination of Diagnostic Accuracy and Added Value of Vasovist®-Enhanced Peripheral MRA in Comparison to Intra-arterial Digital Subtraction Angiography (i.a. DSA) in Patients With Peripheral Artery Disease
Brief Summary 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.
Detailed Description 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Peripheral Arterial Occlusive Disease
Intervention  ICMJE Procedure: Diagnostic MR-Angiography
Single MR-Angiography of the lower extremity after the bolus injection 0.03mmol/kg BW Vasovist
Other Names:
  • Vasovist(R)
  • generic name - gadofosveset
Study Arms  ICMJE Experimental: 1
single arm study, all patients will undergo Vasovist-enhanced MRA
Intervention: Procedure: Diagnostic MR-Angiography
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: July 15, 2008)
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients who have Fontaine-stage III and IV and an indication for therapeutic i.a. DSA
  • PAOD has to be confirmed by ECCM MRA, CTA, non-selective DSA, Doppler ultrasound (DUS) prior to the study.
  • Patients who are willing to undergo the study MRA procedure with Vasovist
  • Patients who are willing to comply with the study procedures (e.g. being followed-up for 12 hours after the Vasovist injection).
  • Patients who have given their fully informed and written consent voluntarily.

Exclusion Criteria:

  • Being less than 18 years of age.
  • Women who are pregnant, lactating or who are of childbearing potential and have not had a negative urine pregnancy test the same day as administration of Vasovist. The manufacturer's instructions for performing the urinary pregnancy test are to be followed.
  • Patients who are scheduled for any therapy between any of the two procedures (MRA and DSA) that interferes with the comparability of the two angiographic procedures.
  • Having an underlying disease or concomitant medication which may interfere with efficacy or safety evaluations as planned in this study.
  • Having any physical or mental status that interferes with the informed consent procedure including self-signed consent.
  • GFR < 30 ml/m²/1.73m² (MDRD), values ≤ 1 week or patients on hemodialysis
  • Renal or liver transplant patients, including patients with scheduled liver transplant are excluded due to the potential risk for nephrogenic systemic fibrosis (NSF).
  • MR contraindications (pacemaker, magnetic clips, severe claustrophobia)
  • Known allergy to Gadofosveset
  • Presenting with history of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents.
  • Untreated significant stenosis in pelvis
  • Known severe coagulopathy (PTT > 25s, Quick < 60%)
  • Having received any investigational drug within 7 days prior to entering this study or who are planned to receive any investigational drug during the safety follow-up period.
  • Not being able to remain lying down for at least 30-45 min (e.g. patients with unstable angina, dyspnea at rest, severe pain at rest, severe back pain).
  • Being clinically unstable and whose clinical course during the 12 hours observation period is unpredictable.
  • Being scheduled for, or likely to require, any surgical intervention within 12 hours before or within the follow-up period.
  • Patients in whom i.a. DSA is contra-indicated preventing him/her from undergoing standard of reference (SOR) procedure.
  • Close affiliation with the investigational site; e.g. a close relative of the investigator.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00717639
Other Study ID Numbers  ICMJE Vasovist MA-01
EudraCT 2007-006014-41
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Henrik Michaely (Principal Investigator), University of Heidelberg
Study Sponsor  ICMJE Heidelberg University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Henrik J Michaely, MD Heidelberg University
Study Director: Stefan O Schoenberg, MD Heidelberg University
PRS Account Heidelberg University
Verification Date July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP