NL-OMON55992招募中不适用
Treatment of type II Endoleaks with ANEUFIX: assessment of safety, performance and clinical benefit.. - Aneufix for Edoleak TII
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
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
- •1. Persistent type II endoleak (more than 6 months post-EVAR or
- •post-embolization procedure); AND
- •2. Volume of the 'endoleak void' can be estimated upfront; AND
- •3. 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
- •4. 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
- •(alternative imaging technique) and based upon sac diameter measurements; AND
- •5. An aneurysm sac that can be punctured in translumbar approach; AND
- •6. Possibility to withhold anti-thrombogenic medication temporarily; AND
- •7. Ability and willingness to undergo the translumbar procedure; AND
- •8. Be older than 18 years.
排除标准
- •1. Patient not able or willing to give written Informed Consent themselves; OR
- •2. Patient undergoing emergency procedures; OR
- •3. Patient with traumatic vascular injury; OR
- •4. Patient with an untreated endoleak connected to an open AMI (patients
- •can be included if the AMI is coiled or is technically not possible to be
- •coiled prior the Aneufix application); OR
- •5. Patient with hemostatic disorder (including bleeding disorders) or who is
- •clinically unstable; OR
- •6. Patient with a too high risk of abdominal sac rupture to allow safe
- •radiological and scanographic assessments; OR
- •7. Patient who is allergic to contrast media or anticoagulants; OR
- •8. Patient with renal impairment (eGRF < 30 ml/min); OR
- •9. Patient with a contra-indication for temporal positioning of a translumbar
- •needle/catheter; OR
- •10. 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
- •11. Pre-menopausal women, OR
- •12. Patient with a life expectancy of less than 12 months; OR
- •13. Patient with an intra aneurysm systolic blood pressure > 125 mmHg
研究者
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