Feasibility Assessment of the Prophylactic Use of AneuFix at the Time of EVAR Implantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Technical Success
研究概览
简要总结
This study is set up to assess the feasibility and safety of the clinical procedure using AneuFix in a prophylactic setting at the time of EVAR endograft implantation.
详细描述
The investigational device is called ANEUFIX, which is a product treating the endoleak by blockage of backflowing blood vessels, i.e. by filling the endoleak void and nidus of feeding artery and exit of existing draining arteries.
ANEUFIX is a polymer that cures rapidly (2-4 min at 37°C) after injection into the AAA-sac close to the nidus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Asymptomatic, infrarenal AAA that requires surgery with a high-risk profile of developing endoleak type II in line with the recommendations of Guntner et al:
- •Open IMA AND
- •1 patent lumbar AND a cross-sectional area at the location of the IMA (CSAIMA) >17,5cm2 OR
- •2 patent lumbars AND a CSAIMA >15cm2 OR
- •3 patent lumbars AND a CSAIMA >12,5 cm2 OR
- •4 patent lumbars AND a CSAIMA >10 cm2 OR
- •5 patent lumbars AND a CSAIMA >7,5 cm2
- •Infrarenal neck according to the IFU of the EVAR device
- •Other aortic-iliac anatomical configuration suitable for EVAR according to the criteria of the EVAR device to be used
- •Patient having a life expectation of at least 2 years
- •Being older than 18 years
- •Willing and able to comply with the requirements of this clinical study
排除标准
- •Patient not able or willing to give written Informed Consent
- •Patient undergoing emergency procedures
- •Patient undergoing EVAR for ruptured or symptomatic AAA,
- •Patient with a suprarenal AAA
- •Patient with an inflammatory AAA (more than minimal wall thickening)
- •Patient with an infrarenal neck unsuitable for endovascular fixation (including so called "hostile necks") or aortic-iliac anatomic configuration otherwise unsuitable for EVAR according to criteria of the device to be used
- •Patient in which a bilateral retroperitoneal incision is required for EVAR
- •Patient in which a sacrifice of both hypogastric arteries is required
- •Patient with anatomical variations, i.e. horseshoe-kidney, arteries requiring reimplantation
- •Patient in which the administration of contrast agent is not possible: proved, severe systemic reaction to contrast agent
- •Patient with active infection present
- •Patients scheduled for or having received an organ transplant
- •Patient with limited life expectation due to other illness (<1 year)
- •Patient with non-iatrogenic bleeding diathesis
- •Patient with connective tissue disease
- •Women of child-bearing potential
- •Patients with evidence at completion angiogram during EVAR of a type Ia or type III endoleak persistent after balloon inflation
结局指标
主要结局
Technical Success
时间窗: 24 hours
Technical Success as demonstrated by the feasibility to fill the AAA sac after EVAR during the same procedure, and by the rate of (all) endoleaks after EVAR followed by the AneuFix procedure
Clinical Success rate
时间窗: 12 months
Clinical Success as demonstrated by the occurrence of type II endoleaks at 12 months after EVAR, and aneurysmal sac growth at 12 months after EVAR
次要结局
- Peri-operative complications(30 days)
- Proportion of patients surviving 24 months after treatment(24 months)
- Prevention of (any type of) endoleak(1, 6 and 12 months)
- Intraoperative occurrence of complications(24 hours)
- adverse events(1, 6 and 12 months)
- Aneurysm rupture(6 and 12 months)
- Re-interventions(1, 6 and 12 months)