ANEUFIX for Endoleaks Type II

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'.

Inclusion criteria

• 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.

Exclusion criteria

• 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.