Renal MRA Crossover Study Comparing Multihance to Another Contrast Agent

Phase 3

Completed

• Conditions: Steno-occlusive Disease
• Interventions: Drug: Multihance; Drug: vasovist

• Registration Number: NCT00415805
• Lead Sponsor: Bracco Diagnostics, Inc

Brief Summary

This is an explorative small pilot study comparing two MRA contrast agents, one of which has been on the market for a few years and the other fairly new to the market. Since the study is explorative and designed to provide preliminary information for consideration for a future larger study, sample size is not based on statistical assumptions.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2006-12-22
• Study First Submitted QC: 2006-12-23
• Study First Posted: 2006-12-25
• Primary Completion: 2008-12
• Study Completion: 2009-02
• Status Verified: 2009-03
• Last Update Submitted: 2023-07-31
• Last Update Posted: 2023-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• Known or suspected renovascular disease based on one of the following criteria:

  • severe hypertension
  • hypertension refractory to standard therapy
  • abrupt onset of moderate to severe hypertension at age < 35 years
  • normalized blood pressure by an ACE inhibitor in a patient with moderate or severe hypertension
  • unexplained by stable elevation of serum creatinine > 2Mg/dL
  • positive findings for stenosis from another imaging modality

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Multihance	-
2	vasovist	-

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity compared to DSA	post dose

Secondary Outcome Measures

Name	Time	Method
accuracy and predictive values; inter-reader agreement for diagnostic performance	post dose

Trial Locations

Locations (1)

Bracco Imaging, S.p.A; 🇮🇹 Milan, Italy