NCT00408083已完成3 期
A Phase IIIB, Double-Blind, Multi-Center, Randomized, Cross-Over Study to Compare 0.1 Mmol/kg of Multihance With 0.1 Mmol/kg of Magnevist for Contrast-Enhanced Magnetic Resonance Angiography(CE-MRA) of Peripheral Arteries
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Assessment of global paired diagnostic preference of the two MRA exams
研究概览
简要总结
This is a double blind crossover study designed to compare two different gadolinium products given at the same dose to patients undergoing MRA assessment of lower legs for the evaluation of peripheral steno-occlusive disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •At least 18 yrs of age
- •Moderate to severe peripheral arterial disease
- •Willing to undergo two MRA procedures within 14 days
排除标准
- •Pregnant or lactating
- •Known allergies to one or more ingredients in the products
- •Therapeutic intervention in the arterial territory of interest between the two MRA exams
- •Changes in symptoms between the two exams
- •Vascular stent in area of interest
- •Severe claustrophobia
- •Congestive heart failure class IV
- •Scheduled to undergo surgery for PAOD between the two exams
- •Scheduled to undergo DSA between the two exams
研究组 & 干预措施
1
Experimental
MultiHance MRI contrast agent
干预措施: MultiHance (Drug)
2
Active Comparator
Magnevist contrast agent for MRA
干预措施: Magnevist (Drug)
结局指标
主要结局
Assessment of global paired diagnostic preference of the two MRA exams
时间窗: Post dose
次要结局
- To compare the two different products for signal intensity enhancement; average quality of visualization; technical failure rate; to assess inter-reader agreement in terms of average quality of visualization(post dose)
研究者
研究点 (1)
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