NCT00955617已完成4 期
Intra-individual Efficacy Evaluation of DOTAREM®-Enhanced MRA Compared to GADOVIST®-Enhanced MRA in the Diagnosis of Clinically Significant Abdominal or Lower Limb Arterial Diseases
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Guerbet
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Overall Image Quality of MRA Images
研究概览
简要总结
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.
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
- •Female or male, aged ≥ 18 years
- •Patient suffering from Peripheral Arterial Occlusive Disease (PAOD) stage II or III.
排除标准
- •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.
结局指标
主要结局
Overall Image Quality of MRA Images
时间窗: MRA examination
Number of images quoted with excellent and more than adequate quality in each group. Image quality will be assessed on a 5-point scale: 1. Excellent 2. More than adequate 3. Adequate 4. Less than adequate 5. Non-diagnostic Each image is analysed by 4 readers.
次要结局
- Diagnostic Confidence(MRA examination)
- Signal Intensity(MRA examination)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Efficacy Evaluation of Dotarem®-Enhanced MRI Compared to Gadovist®/Gadavist®-Enhanced MRI in the Diagnosis of Brain TumorsPrimary Brain TumorNCT02034708Guerbet279
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
已完成
4 期
Efficacy Evaluation of Dotarem Compared to Gadovist in the Diagnosis of Peripheral Arterial DiseasePeripheral Arterial DiseaseNCT01026389Guerbet189
已完成
3 期
Carotid and Vertebral Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF)Cerebral Arterial DiseasesNCT01010932Guerbet222
已完成
3 期
Carotid and Vertebral Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF)Cerebral Arterial DiseasesNCT01012674Guerbet211