Vasovist Magnetic Resonance Angiography (MRA) in Peripheral Arterial Occlusive Disease - Full Text View

Purpose

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.

Condition	Intervention	Phase
Peripheral Arterial Occlusive Disease	Procedure: Diagnostic MR-Angiography	Phase 4

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Peripheral Arterial Disease

Drug Information available for: Gadofosveset trisodium

U.S. FDA Resources

Further study details as provided by University of Heidelberg:

Primary Outcome Measures:

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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of correct stenosis gradings (<50%, 50-99%, occlusion) of Vasovist® enhanced MRA compared to DSA [ Time Frame: End of study ] [ Designated as safety issue: No ]
Sensitivity and specificity (<50%, >=50%) of Vasovist enhanced MRA compared to DSA [ Time Frame: End of study ] [ Designated as safety issue: No ]
Length of stenosis (target) of Vasovist® enhanced MRA compared to DSA [ Time Frame: End of study ] [ Designated as safety issue: No ]
Correlation of the description of the inflow, target, outflow of Vasovist® enhanced MRA (combined) compared to DSA [ Time Frame: End of study ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Additional venous pathologies [ Time Frame: End of study ] [ Designated as safety issue: No ]
Diagnostic confidence of Vasovist enhanced MRA and DSA [ Time Frame: End of study ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	May 2008
Study Completion Date:	July 2010
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00717639

Locations

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

Sponsors and Collaborators

University of Heidelberg

Investigators

Principal Investigator:	Henrik J Michaely, MD	University of Heidelberg
Study Director:	Stefan O Schoenberg, MD	University of Heidelberg

More Information

No publications provided

Responsible Party:	Henrik Michaely (Principal Investigator), University of Heidelberg
ClinicalTrials.gov Identifier:	NCT00717639 History of Changes
Other Study ID Numbers:	Vasovist MA-01, EudraCT 2007-006014-41
Study First Received:	June 30, 2008
Last Updated:	August 5, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Spain: Ministry of Health and Consumption Switzerland: Swissmedic

Keywords provided by University of Heidelberg:

diagnostic accuracy
magnetic resonance angiography
steady state
digital subtraction angiography
peripheral arteries

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Peripheral Arterial Disease
Vascular Diseases
Cardiovascular Diseases

Atherosclerosis
Arteriosclerosis
Peripheral Vascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013