Phase 4
N=20
DOTAREM®-Enhanced MRA Compared to GADOVIST®-Enhanced MRA in Patients With Abdominal or Lower Limb Arterial Diseases
Peripheral Arterial Disease
Bottom Line
View on ClinicalTrials.gov: NCT00955617 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Nov 2012
Primary outcome: Primary: Overall Image Quality of MRA Images — 56; 48 Images
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Contrast-enhanced MRA - Imaging examination (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Guerbet
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Image Quality of MRA Images |
56; 48 | — |
| SECONDARY Diagnostic Confidence |
55; 50 | — |
| SECONDARY Signal Intensity |
23; 26 | — |
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 Criteria
- Female or male, aged ≥ 18 years
- Patient suffering from Peripheral Arterial Occlusive Disease (PAOD) stage II or III.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00955617). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.