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Omniscan for MRA of Aorto-iliac Arteries
NCT00209443Phase 3
Key facts
- Status
- Completed
- Start
- Sep 2004
- Primary completion
- Feb 2006
- Countries
- 1
- Sponsor
- GE HealthCare
- Modality
- Small Molecules
- Drugs
- gadodiamide
- Conditions
- aortoiliac occlusive disease (AIOD)
01
Overview
Phase 3, open-label, single-arm trial of gadodiamide in aortoiliac occlusive disease (AIOD), sponsored by GE HealthCare. Primary endpoints: Sensitivity in detecting stenosis (>50% occlusion) at 27 hours and Specificity in detecting stenosis (>50% occlusion) at 27 hours. Started Sep 2004; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Gadodiamide Injection
Subjects receive Omniscan 0.1 mmol/kg for MRA
03
Who it enrols
Adults with confirmed or suspected aorto-iliac stenosis referred for Digital Subtraction Angiography. Excludes patients with serum creatinine >= 3.5 mg/dL, metal implants in the region, or contraindications to MRI.
04
Endpoints
Primary
Sensitivity in detecting stenosis (>50% occlusion)
Specificity in detecting stenosis (>50% occlusion)
Secondary
Diagnostic Accuracy
Positive Predictive Value
Negative Predictive Value
Revascularisation strategies based on imaging
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