NCT00447889

Brief Summary

This is a clinical study of gadoteric acid in non-coronary MR angiography.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 14, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 15, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

November 26, 2008

Status Verified

November 1, 2008

Enrollment Period

1.7 years

First QC Date

March 14, 2007

Last Update Submit

November 25, 2008

Conditions

Arterial Occlusive Disease

Interventions

gadoteric acidDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, at least the age of legal maturity
  • Strongly suspected of having non-coronary arterial disease, detected clinically
  • Scheduled to undergo x-ray angiography examination
  • Female patients must be using effective contraception or be surgically sterilized or post-menopausal.
  • Females of childbearing potential must have a documented negative urine pregnancy test.

You may not qualify if:

  • Contraindication to magnetic resonance imaging (MRI)
  • Any metallic medical device in the vascular territory for which the patient is to undergo imaging examinations
  • Congenital morphologic vascular abnormalities
  • Known allergy to gadolinium chelates
  • Pregnant, breast feeding, or planning to become pregnant during the trial
  • Received a gadolinium complex within 2 days or iron oxide nanoparticles within 7 days before the gadoteric acid-enhanced magnetic resonance angiography (MRA) examination.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Arterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Corinne Dubourdieu, PhD

    Guerbet

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 14, 2007

First Posted

March 15, 2007

Study Start

March 1, 2006

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

November 26, 2008

Record last verified: 2008-11

Locations

KR(1)