Feasibility Study of Treatment Type II Endoleaks With ACP-T5: a Novel Approach.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 4
- 主要终点
- Technical success of Type II endoleak repair with Aneufix ACP-T5 as demonstrated by the absence of an endoleak at the end of the procedure.
研究概览
简要总结
The study is a non-randomized, multi-center safety and feasibility trial of Aneufix ACP-T5 to treat patients with Isolated type II endoleak in the presence of a non-shrinking AAA sac following an EVAR procedure.
详细描述
The investigational device is called Aneufix, more specifically the model ACP-T5, 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'.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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 IIa or IIb endoleak (more than 6 months post-EVAR or post-embolization procedure); AND
- •Volume of the 'endoleak void' can be determined upfront; AND
- •An EVAR without circulatory complications; AND
- •An endoleak confirmed by CT scan in preceding 6 weeks demonstrating the high likelihood of the isolated nature of the endoleak; AND
- •An aneurysm sac growing in contours after EVAR (per European Guidelines) as documented in the preceding 6 weeks by means of echo (or alternative visualization technique); AND
- •An aneurysm sac that can be punctured in translumbar approach ; AND
- •Possibility to withhold anti-thrombogenic medication temporarily; AND
- •Ability and willingness to undergo the translumbar procedure under local anesthesia in a CT scan; AND
- •Be 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 hemostatic disorder 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 (serum creatinine > 2 mg/dl or > 176 mmol/l); OR
- •Patient who is participating in another trial with an investigational drug or medical device; OR
- •Women of child-bearing potential; OR
- •Patient with a life expectancy of less than 12 months.
结局指标
主要结局
Technical success of Type II endoleak repair with Aneufix ACP-T5 as demonstrated by the absence of an endoleak at the end of the procedure.
时间窗: 24h
At the end of the injection procedure, the technical success will be determined by angiographic recording and physician assessment of absence of endoleak. CT scan at 24 hrs is obtained to reconfirm the absence of endoleak.
次要结局
- Clinical succes rate.(6 and 12 months)
- Safety aspects I : intra-operative complication rate.(All complications observed during the ACP-T5 injection procedure are documented.)
- Safety aspects II: Peri-operative complication rate.(1 month)
- Safety aspects III : Mid- and long-term complication rate.(1-12 months)
- Aneurysm sac rupture.(12 months)
- Survival.(24 months.)