Crossover Study With MultiHance vs a Comparator for Perip... | NCT00408083

Studies
Crossover Study With MultiHance vs a Comparator for Peripheral MRA

NCT00408083

Sponsor

Bracco Diagnostics, Inc

Status

Completed

Last Update Posted

Mar 27, 2009Estimated

Enrollment

100Estimated

Phase

Phase 3

Conditions

Peripheral Vascular Disease

Interventions

MultiHance
Magnevist

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2006

Primary Completion Date

Nov 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Dec 4, 2006

First Submission Date that Met QC Criteria

Dec 4, 2006

First Posted Date

Dec 6, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2009

Last Update Posted Date

Mar 27, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	MultiHance MRI contrast agent	Drug: MultiHance
2	Active Comparator	Magnevist contrast agent for MRA	Drug: Magnevist

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MultiHance	Drug	0.5 mmol/kg as a single dose administration	1
Magnevist

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assessment of global paired diagnostic preference of the two MRA exams		Post dose

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gianpaolo Pirovano, MD	Bracco Diagnostics, Inc	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bracco Imaging		Milan		20134	Italy

Condition Browse Module

MeSH Terms

ID	Term
D016491	Peripheral Vascular Diseases

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C064572	gadobenic acid
D019786	Gadolinium DTPA

Ancestor Terms

ID	Term
D004369	Pentetic Acid
D011073	Polyamines
D000588	Amines
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided