NCT01026389已完成4 期
Efficacy Evaluation of Dotarem®-Enhanced MRA Compared to Gadovist®-Enhanced MRA in the Diagnosis of Clinically Significant Abdominal or Limb Arterial Diseases
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Guerbet
- 入组人数
- 189
- 试验地点
- 1
- 主要终点
- Intra-patient Accuracy (Percent Agreement), On-site Data
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •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.
排除标准
- •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.
研究组 & 干预措施
Gadovist
Active Comparator
Patient received contrast-enhanced MRA with Gadovist
干预措施: Gadovist (Drug)
Dotarem, interventional
Experimental
Patients received contrast-enhanced MRA with Dotarem
干预措施: Dotarem (Drug)
结局指标
主要结局
Intra-patient Accuracy (Percent Agreement), On-site Data
时间窗: up to one month
intra-patient accuracy (percent agreement) of each type of MRA examination (Dotarem® or Gadovist®-enhanced MRA) in assessing the lesions of the concerned territory as compared with the gold standard, X-ray angiography.
次要结局
- Intra-patient Accuracy, in Off-site Readings(up to one month)
- Specificity(up to one month)
- Sensitivity(up to one month)
研究者
研究点 (1)
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进行中（未招募）
不适用
Efficacy evaluation of DOTAREM-enhanced MRA compared to GADOVIST-enhanced MRA in the diagnosis of clinical significant abdominal or lower limb arterial diseases - NDPatients suffering from abdominal or lower limb arterial diseasesMedDRA version: 12.0Level: LLTClassification code 10062585Term: Peripheral arterial occlusive diseaseEUCTR2009-010968-42-ITGUERBET188