Vasovist Magnetic Resonance Angiography (MRA) in Peripheral Arterial Occlusive Disease
NCT ID: NCT00717639
Last Updated: 2011-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
150 participants
INTERVENTIONAL
2008-05-31
2010-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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1
single arm study, all patients will undergo Vasovist-enhanced MRA
Diagnostic MR-Angiography
Single MR-Angiography of the lower extremity after the bolus injection 0.03mmol/kg BW Vasovist
Interventions
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Diagnostic MR-Angiography
Single MR-Angiography of the lower extremity after the bolus injection 0.03mmol/kg BW Vasovist
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Heidelberg University
OTHER
Responsible Party
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University of Heidelberg
Principal Investigators
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Henrik J Michaely, MD
Role: PRINCIPAL_INVESTIGATOR
Heidelberg University
Stefan O Schoenberg, MD
Role: STUDY_DIRECTOR
Heidelberg University
Locations
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University Medical Center Mannheim
Mannheim, , Germany
University of Munich
Munich, , Germany
Countries
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Other Identifiers
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EudraCT 2007-006014-41
Identifier Type: -
Identifier Source: secondary_id
Vasovist MA-01
Identifier Type: -
Identifier Source: org_study_id
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