Status:
COMPLETED
DOTAREM®-Enhanced MRA Compared to GADOVIST®-Enhanced MRA in Patients With Abdominal or Lower Limb Arterial Diseases
Lead Sponsor:
Guerbet
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study is an intra-individual comparison of DOTAREM®-enhanced MRA and GADOVIST®-enhanced MRA in the diagnosis of clinically significant abdominal or lower limb arterial diseases.
Eligibility Criteria
Inclusion
- Female or male, aged ≥ 18 years
- Patient suffering from Peripheral Arterial Occlusive Disease (PAOD) stage II or III.
Exclusion
- Patients with severely impaired renal function with an eGFR (MDRD) \< 50ml/min (eGFR based on recent serum creatinine and MDRD formula - younger than 21 days).
- Patient planned to undergo therapeutic intervention in the vessels of interest between the two MRA procedures.
- Patient who had a major cardiovascular event within 30 days prior to the inclusion.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00955617
Start Date
July 1 2009
End Date
October 1 2010
Last Update
November 2 2012
Active Locations (1)
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1
Guerbet
Roissy CDG, France