Treatment of Type II Endoleak With ANEUFIX: Assessment of Safety, Performance and Clinical Benefit.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 9
- 主要终点
- Technical success rate
研究概览
简要总结
The study is non-randomized, multicenter international safety, performance and clinical benefit outcome assessment of ANEUFIX to treat patients with isolated type II endoleak in the presence of a growing AAA-sac following an EVAR procedure more than 6 months ago.
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
- •Persistent type II endoleak (more than 6 months post-EVAR or post-embolization procedure); AND
- •An endoleak confirmed on a CT scan that should be done within 180 days prior to procedure but preferably within 90 days prior to screening demonstrating the high likelihood of the isolated nature of the endoleak; AND
- •An aneurysm sac growing after EVAR of minimal 10 mm (per European Guidelines) as documented in the preceding 90 days by means of CT-imaging (or alternative imaging techniques) and based upon sac diameter measurements; AND
- •An aneurysm sac that can be punctured via a translumbar approach; AND
- •Possibility to withhold anti-thrombogenic medication temporarily; AND
- •Ability and willingness to undergo the translumbar procedure; AND
- •Being older than 18 years.
排除标准
- •Patient not able or willing to give written Informed Consent; OR
- •Patient undergoing emergency procedures; OR
- •Patient with traumatic vascular injury; OR
- •Patient with haemostatic disorder (including bleeding disorders) or who is clinically unstable; OR
- •Patient with a too high risk of abdominal sac rupture to allow safe radiological and scanographic assessments; OR
- •Patient who is allergic to contrast media or anticoagulants; OR
- •Patient with renal impairment (eGFR < 30 ml/min); OR
- •Patient with a contra-indication for temporal positioning of a translumbar needle/catheter; OR
- •Patient who is participating in another trial with an investigational drug or medical device, or where a medical device/drug is used outside its labelling and its approved intended use; OR
- •Pre-menopausal women, OR
- •Patient with a life expectancy of less than 12 months, OR
- •Patient with an intra aneurysm systolic blood pressure > 125 mmHg
结局指标
主要结局
Technical success rate
时间窗: 24 hours
Technical success of Type II endoleak repair with Aneufix as demonstrated by the absence of endoleak circulation at the intended treated endoleak at the end of the procedure; presence or absence of the endoleak treated with ANEUFIX is verified by means of a CT scan the next day.
次要结局
- Occurrence of general adverse events and adverse device effects(1 week and 1, 6, 12 and 24 months)
- serious adverse events, vascular related adverse events and adverse device effects: complications and deaths, re-interventions, aneurysm rupture(During the Aneufix procedure)
- Intra- and peri-operative complications(30 days)
- Rate of aneurysm rupture(6,12 and 24 months)
- Absence of aneurysm sac growth(6, 12 and 14 months)
- Rate of re-interventions(1, 6, 12 and 24 months)
- Survival rate(24 months)