CE-MRA Using Gadovist in Comparison to IA DSA Using Ultravist

NCT ID: NCT00154648

Last Updated: 2007-06-05

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Brief Summary

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This trial is to show the diagnostic efficacy of Gadovist for contrast enhanced magnetic resonance angiography (CE-MRA) of the arteries.

Detailed Description

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This trial is to show the diagnostic efficacy of Gadovist for contrast enhanced Magnetic Resonance Angiography (CE-MRA) of arteries (specified vessel segments) by analyzing the rate of agreement, image quality, and diagnostic confidence between a CE-MRA based diagnosis and the diagnosis achieved from the comparator procedure IA DSA using Ultravist.

Conditions

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Angiography, Digital Subtraction Magnetic Resonance Angiography

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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CE-MRA

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* With suspected or known disease of the arteries
* Scheduled for an IA DSA/cut film angiography of the arteries in a period of less than 7 days prior to or after the study period and has completed delineation and documentation of all vessels.
* Willing and able to continue study participation. This includes the administration of Gadovist® 1.0 and completion of all procedures required by the study protocol
* Patient is between 20 and 75 years of age
* Fully informed and has signed consent in advance

Exclusion Criteria

* Patient is clinically unstable or his/her clinical course during the 72 hour safety observation period was unpredictable
* Patient with renal failure
* Woman who is pregnant or of childbearing potential without having had a negative pregnancy test prior to enrollment (within 72 hours prior to CE-MRA)
* Lactating woman
* Patient with any contraindication to magnetic resonance imaging (MRI) examination and IA DSA.
* Patient receives any investigational drug within 30 days prior to study entry or is planned to receive any other investigational drug during the safety follow-up (72 hours after CE-MRA).
* Patient is scheduled for surgery or other interventions within the 72 hours after the CE-MRA/IA DSA or had any such procedure within 48 hours prior to the study CE-MRA/IA DSA.
* Hypersensitivity to gadobutrol products
* Patient has previously entered this study
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Hon-Man Liu, MD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Hon-Man Liu, MD

Role: CONTACT

23123456 ext. 2570

Facility Contacts

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Hon-Man Liu, MD

Role: primary

23123456 ext. 2570

Other Identifiers

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0941540200

Identifier Type: -

Identifier Source: org_study_id