Evaluation of Dotarem-enhanced MRA Compared to Time-Of-Flight (TOF) MRA in the Diagnosis of Carotid and Vertebral Basilar Arterial Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Guerbet
- 入组人数
- 222
- 试验地点
- 1
- 主要终点
- Technical Failure Rate
研究概览
简要总结
The study will evaluate the efficacy and safety of Dotarem enhanced MRA in patients suffering from carotid or vertebral arterial disease.
详细描述
Each subject will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem enhanced MRA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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 more than 18 years
- •Strongly suspected of having carotid or vertebral arterial disease
- •Scheduled (or to be scheduled) to undergo computed tomography angiography (CTA) examination
排除标准
- •Known grade IV or V chronic kidney disease (GFR<30 mL/min/1.73m²)
- •Contraindication to MRI
- •Acute renal dysfunction within the 6 months preceding Dotarem®-enhanced MRA examination
研究组 & 干预措施
Dotarem and TOF MRA
Each subject will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem enhanced MRA.
干预措施: Dotarem (Drug)
Dotarem and TOF MRA
Each subject will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem enhanced MRA.
干预措施: TOF MRA (Other)
结局指标
主要结局
Technical Failure Rate
时间窗: 2 - 28 days
Rate of non-assessable arterial segments as measured by 3 independent readers in off-site evaluation of TOF-MRA and Dotarem-enhanced MRA (re-read DGD-44-060).
Specificity
时间窗: 2 - 42 days
Rate of true non-stenotic segments (i.e. without stenosis \>= 70%) of TOF and Dotarem-enhanced MRA evaluated by 3 independent off-site readers at the segment level, with CTA as standard of truth (re-read DGD-44-060).
Sensitivity
时间窗: 2-42 days
Rate of true stenotic segments (i.e. with stenosis \>= 70%) of TOF and Dotarem-enhanced MRA evaluated by 3 independent off-site readers at the segment level, with CTA as standard of truth (re-read DGD-44-060).
次要结局
未报告次要终点