NL-OMON48581已完成不适用
Feasibility study of treatment type II Endoleaks with ACP-T5: a novel approach - ANEUFIX ACP-T5
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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 8 weeks demonstrating the high
- •likelihood of the isolated nature of the endoleak; AND
- •- An aneurysm sac either growing in contours after EVAR (per European
- •Guidelines) as documented in the preceding 8 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
- •-Patients 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 risk of abdominal sac rupture too high to allow safe
- •radiological and scanographic assessments;
- •- 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.
研究者
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