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

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

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.

Study Overview

• Status: Terminated
• Conditions: Peripheral Arterial Occlusive Disease
• Intervention / Treatment: Procedure: Diagnostic MR-Angiography

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: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Mannheim, Germany, 68167
    • University Medical Center Mannheim
  • Munich, Germany, 81377
    • University of Munich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; single arm study, all patients will undergo Vasovist-enhanced MRA	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Accuracy of quantitative stenosis grading (<50%, >=50%) of Vasovist enhanced MRA with regard to i.a. DSA as standard of reference	End of study (anticipated Sep 2009)

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of correct stenosis gradings (<50%, 50-99%, occlusion) of Vasovist® enhanced MRA compared to DSA	End of study
Sensitivity and specificity (<50%, >=50%) of Vasovist enhanced MRA compared to DSA	End of study
Length of stenosis (target) of Vasovist® enhanced MRA compared to DSA	End of study
Correlation of the description of the inflow, target, outflow of Vasovist® enhanced MRA (combined) compared to DSA	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	End of study
Additional venous pathologies	End of study
Diagnostic confidence of Vasovist enhanced MRA and DSA	End of study

Collaborators and Investigators

• Sponsor: Heidelberg University
• Investigators: Principal Investigator: Henrik J Michaely, MD, Heidelberg University; Study Director: Stefan O Schoenberg, MD, Heidelberg University

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: June 30, 2008
• First Submitted That Met QC Criteria: July 15, 2008
• First Posted (Estimate): July 17, 2008

Study Record Updates

• Last Update Posted (Estimate): August 8, 2011
• Last Update Submitted That Met QC Criteria: August 5, 2011
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: diagnostic accuracy; magnetic resonance angiography; steady state; digital subtraction angiography; peripheral arteries
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease; Arterial Occlusive Diseases
• Other Study ID Numbers: Vasovist MA-01; EudraCT 2007-006014-41

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No