Status:
TERMINATED
Renal Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF)
Lead Sponsor:
Guerbet
Conditions:
Renal Artery Stenosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The study will evaluate the efficacy and safety of Dotarem enhanced MRA compared to TOF MRA in patients suffering from renal arterial disease.
Detailed Description
Each participant will undergo first a TOF MRA followed by a Dotarem-enhanced MRA.
Eligibility Criteria
Inclusion
- Male or female, aged more than 18 years,
- Strongly suspected of having renal arterial disease,
- Scheduled (or to be scheduled) to undergo arterial catheter-based X-ray angiography examination,
Exclusion
- Known grade IV or V chronic kidney disease (GFR\<30 mL/min/1.73m²),
- Contraindication to MRI,
- Acute renal dysfunction within the 6 months preceding Dotarem®-enhanced MRA examination,
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00845702
Start Date
April 1 2009
End Date
February 1 2010
Last Update
May 20 2016
Active Locations (1)
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1
Guerbet LLC
Bloomington, Indiana, United States, 47403