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

NCT ID: NCT00717639

Last Updated: 2011-08-08

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2010-07-31

Brief Summary

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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

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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.

Conditions

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Peripheral Arterial Occlusive Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

single arm study, all patients will undergo Vasovist-enhanced MRA

Group Type EXPERIMENTAL

Diagnostic MR-Angiography

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Other Intervention Names

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Vasovist(R) generic name - gadofosveset

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heidelberg University

OTHER

Sponsor Role lead

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

Site Status

University of Munich

Munich, , Germany

Site Status

Countries

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Germany

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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