Feasibility study of ANEUFIX : a novel, first in man approach to treat Type II Endoleaks using ACP-T5. - Aneufix ACP-T5

TripleMed B.V.0 个研究点目标入组 5 人开始时间: 待定最近更新: 2024年4月23日

试验速览

暂无简介。

•- 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 from minimally two directions; ANDPossibility 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

•- 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; 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
•- Patient with a life expectancy of less than 12 months.

发起方