NCT00408083

Brief Summary

This is a double blind crossover study designed to compare two different gadolinium products given at the same dose to patients undergoing MRA assessment of lower legs for the evaluation of peripheral steno-occlusive disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 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

December 1, 2006

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 6, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

March 27, 2009

Status Verified

March 1, 2009

Enrollment Period

1.9 years

First QC Date

December 4, 2006

Last Update Submit

March 25, 2009

Conditions

Peripheral Vascular Disease

Outcome Measures

Primary Outcomes (1)

  • Assessment of global paired diagnostic preference of the two MRA exams

    Post dose

Secondary Outcomes (1)

  • To compare the two different products for signal intensity enhancement; average quality of visualization; technical failure rate; to assess inter-reader agreement in terms of average quality of visualization

    post dose

Study Arms (2)

1

EXPERIMENTAL

MultiHance MRI contrast agent

Drug: MultiHance

2

ACTIVE COMPARATOR

Magnevist contrast agent for MRA

Drug: Magnevist

Interventions

MultiHanceDRUG

0.5 mmol/kg as a single dose administration

1
MagnevistDRUG

0.5 mmol/kg as a single dose administration

2

Eligibility Criteria

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

You may qualify if:

  • Written informed consent
  • At least 18 yrs of age
  • Moderate to severe peripheral arterial disease
  • Willing to undergo two MRA procedures within 14 days

You may not qualify if:

  • Pregnant or lactating
  • Known allergies to one or more ingredients in the products
  • Therapeutic intervention in the arterial territory of interest between the two MRA exams
  • Changes in symptoms between the two exams
  • Vascular stent in area of interest
  • Severe claustrophobia
  • Congestive heart failure class IV
  • Scheduled to undergo surgery for PAOD between the two exams
  • Scheduled to undergo DSA between the two exams

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bracco Imaging

Milan, 20134, Italy

Location

MeSH Terms

Conditions

Peripheral Vascular Diseases

Interventions

gadobenic acidGadolinium DTPA

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pentetic AcidPolyaminesAminesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsCoordination Complexes

Study Officials

  • Gianpaolo Pirovano, MD

    Bracco Diagnostics, Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 4, 2006

First Posted

December 6, 2006

Study Start

December 1, 2006

Primary Completion

November 1, 2008

Study Completion

December 1, 2008

Last Updated

March 27, 2009

Record last verified: 2009-03

Locations

IT(1)