Pre-emptive Abdominal Aortic Aneurysm Sac Embolization During Endovascular Abdominal Aortic Repair for Infrarenal Abdominal Aortic Aneurysm - Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 124
- 主要终点
- AAA diameter and volume changes/sac regression during follow-up, measurement on control CT with automatic volume software program
研究概览
简要总结
Pre-emptive abdominal aortic aneurysm sac embolization during endovascular abdominal aortic repair for infrarenal abdominal aortic aneurysm - Randomized study
详细描述
In all 124 patients will be included, 62 in each group.
The first group (62 patients) with pre-emptive AAA sac embolization during EVAR and the control group consisted of 62 patients without pre-emptive AAA sac embolization.
The primary goal is to investigate AAA shrinkage/diameter changes in the pre-emptive embolization group compared with the non-embolization group. Further, to investigate all endoleaks and secondary interventions during the follow-up and any difference between groups and correlation if any with pre-emptive embolization.
Demographic, comorbidities, antiplatelet and anticoagulation drugs, AAA characteristics, patent lumbal and inferior mesenteric artery, intervention characteristics and follow-up data will be recorded and analysed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with 55mm (male) or 50 mm (female) AAA, available for EVAR
- •> 18 year old
排除标准
- •Not accept to participate
- •Ruptured AAA
- •Outside for instruction for the use EVAR
研究组 & 干预措施
Pre-emptive AAA sac embolization
干预措施: EVAR (Device)
No pre-emtive AAA sac embolization
干预措施: EVAR (Device)
结局指标
主要结局
AAA diameter and volume changes/sac regression during follow-up, measurement on control CT with automatic volume software program
时间窗: 3 years
1. Automatic software measured the maximal AAA diameter in millimetres (mm) on index CT and follow-up control scanning. The same technique and measurement points will be used. Specialised software dedicated to AAA maximal diameter will be used. 2. Automatic software measurement of total volume of AAA in millilitres (ml) on index CT scanning and on control CT scanning. Specialised software will perform measurement and volumetry expressed in millilitres (ml).
AAA diameter and volume changes/sac regression during follow-up, measurement on control CT and/or ultrasound after EVAR.
时间窗: 5 years
Sac regression uses the centerline reconstruction to compare the baseline CT aorta scanning and AAA diameter measurement - maximal AAA diameter in millimetres (mm). Further, total volume measurement in (ml) of AAA and sac changes during the follow-up comparing the index CT scan with control CT or ultrasound scanning.
次要结局
- Endoleak type 2 incidence, on control CT and ultrasound scanning(5 years)
- Secondary interventions, endovascular secondary interventions( additional embolization, a new stent graft deployment etc)(5 years)
研究者
Stevo Duvnjak
Principal investigator
Rigshospitalet, Denmark