EndoVascular Aortic Repair With Sac Embolization for the Prevention of Type II Endoleaks (the EVAR-SE Study)- A Randomized Controlled Multicentre Study in Germany
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 101
- 试验地点
- 3
- 主要终点
- Type II Endoleak at 12 months after procedure
研究概览
简要总结
Beyond a certain threshold diameter, Abdominal aortic aneurysms (AAA) are treated by open surgical repair or, more often by endovascular aortic aneurysm repair (EVAR). The latter involves implantation of a stent-graft and thereby exclusion of the AAA from the blood circuit. Small vessels supplying parts of the bowel or the spine are regularly covered. In a quarter of patients, this may result in an inversion of blood flow in the mentioned vessels, leading to persistent blood flow within the AAA, referred to as type II endoleak (T2EL). Occurrence of T2EL is associated with complications like AAA growth or even rupture.
Secondary interventions to treat T2EL often fail and may be highly invasive. Various risk factors for T2EL have been described. This enables prediction whether a patient is at high risk for T2EL after EVAR. Deployment of metal coils in the aneurysm sac as part of the EVAR procedure can reduce the risk for T2EL.The present study aims to assess the efficacy of sac embolization during EVAR to prevent T2EL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Age ≥18 years
- •Infrarenal AAA ≥50 mm maximum diameter
- •Indication for EVAR within IFU of company
- •Presence of one or both high risk criteria on CT-A: ≥5 patent efferent vessels (inferior mesenteric and/or lumbar artery, and/or median sacral artery) or <40% thrombus at largest AAA diameter
排除标准
- •Ruptured AAA
- •Fenestrated or branched EVAR
- •Concomitant iliac artery aneurysm
- •Non-ability to adhere to the FU protocol
- •Lack of consent
- •Pregnancy
研究组 & 干预措施
standard EVAR
Patients in the standard EVAR arm will receive EVAR without additional coil embolization of the aneurysm sac.
EVAR with SE
Patients in the EVAR-SE arm will receive EVAR with additional coil embolization of the aneurysm sac.
干预措施: Coil embolization of aneurysm sac (Procedure)
结局指标
主要结局
Type II Endoleak at 12 months after procedure
时间窗: 12 months
Evaluation of the T2EL proportion of the intervention group as compared to the control group at 12 months after EVAR treatment as measured by CEUS and/or CT-A
次要结局
- Type II Endoleak during follow up(6 months)
- Re-intervention(12 months)
- Type I or III Endoleak(12 months)
- AAA rupture(12 months)
- Mortality(12 months)
- life quality(12 months)
- AAA morphology(12 months)
研究者
Univ.-Prof. Dr. Dr. med. Daniela Branzan
Principal Investigator
Technical University of Munich