Evaluation of 3D Rotational Angiography After EVAR
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 427
- 试验地点
- 1
- 主要终点
- Effective Dose
研究概览
简要总结
This is a randomized prospective monocentric study to evaluate the benefits of a 3D rotational acquisition (3DRA) to assess technical success after treatment of infra-renal aneurysm with bifurcated endograft. Patients will be randomized between the standard strategy (2D angiography at the end of the procedure and angioCT-scan before discharge) and the new strategy (3DRA at the end of the procedure). Expected findings are a reduction of radiation exposure and contrast medium used during the hospital stay, with a similar resolution between angioCT-scan and 3DRA to depict the main complications after EVAR (occlusion, kinking, endoleak). Furthermore, any complication depicted after 3DRA group could benefit from an additional procedure during the same operating time, and therefore avoid a second intervention for the patient.
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
- 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
- •Patients treated with EVAR for infra-renal aortic aneurysm
- •In a hybrid room
- •With a signed consent
排除标准
- •Pregnant women
- •Patients unable to understand the study protocol or to give their consents
- •Renal insufficiency (eGFR<60mL/min)
- •Ruptured aneurysms and other emergency settings
研究组 & 干预措施
3D rotational angiography (3DRA)
New strategy - Patients benefit from a 3D rotational acquisition at the end of procedure, which offers CT-like reconstructions. If any technical issues is depicted on the 3DRA, it can be treated during the same operating time. A contrast-enhanced ultrasound is performed for each patient before discharge to confirm that no technical issue was missed by the 3DRA.
干预措施: 3D rotational angiography (3DRA) (Radiation)
2D Angiography (2DA)
Standard of care - Patients benefit from a 2D completion angiogram at the end of the procedure, and from a angioCT-scan before discharge. If any technical issues is depicted on the CT-scan, a new intervention needs to be scheduled.
结局指标
主要结局
Effective Dose
时间窗: Single 1 day - At patient discharge
Total exposure to radiation in mSv
次要结局
- Reintervention rate(During the first 30 days)
- Contrast Medium(Single 1 day - At patient discharge)
- Additional procedure(During surgery)