Phase 4
N=186
Efficacy Evaluation of Dotarem Compared to Gadovist in the Diagnosis of Peripheral Arterial Disease
Peripheral Arterial Disease
Bottom Line
View on ClinicalTrials.gov: NCT01026389 ↗Enrolled (actual)
186
Serious AEs
0.5%
Results posted
Dec 2012
Primary outcome: Primary: Intra-patient Accuracy (Percent Agreement), On-site Data — 77.1; 80.6 percentage of agreement
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dotarem (Drug); Gadovist (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Guerbet
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intra-patient Accuracy (Percent Agreement), On-site Data |
77.1; 80.6 | — |
| SECONDARY Intra-patient Accuracy, in Off-site Readings |
75.1; 73.9 | — |
| SECONDARY Specificity |
756; 763 | — |
| SECONDARY Sensitivity |
168; 191 | — |
Summary
This study is an efficacy evaluation of Dotarem®-enhanced magnetic resonance angiography (MRA) compared to Gadovist®-enhanced MRA in the diagnosis of clinically significant abdominal or lower limb arterial diseases.
Eligibility Criteria
Inclusion Criteria
- Male or female, aged ≥ 18 years.
- Patient with infrarenal aorta or chronic lower limb ischemia with various clinical signs of gravity (stages II-IV according to the classification of Leriche and Fontaine) or/and Doppler ultrasonography indicating abdominal or lower limb arteriopathy.
- Patient scheduled for a conventional X-Ray angiography (intra-arterial Digital Substraction Angiography = DSA) within 30 days of MRA with a minimum time interval of at least 24 hours between the 2 examinations.
Exclusion Criteria
- Patient planned to undergo therapeutic intervention in abdominal or lower limb vessels between the time of MRA and X-ray Angiography will be performed.
- Patient who had a major cardiovascular event within 30 days prior to the inclusion.
- Patient treated with unilateral hip replacement, abdominal aortic or iliac graft or stent.
Data sourced from ClinicalTrials.gov (NCT01026389). 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.