ANEUFIX for Endoleak Type II Repair

Ki vehet részt

• Persistent type II endoleak (more than 6 months post-EVAR or post-embolization procedure); AND
• 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
• 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 (or alternative imaging techniques) and based upon sac diameter measurements; AND
• An aneurysm sac that can be punctured via a translumbar approach; AND
• Possibility to withhold anti-thrombogenic medication temporarily; AND
• Ability and willingness to undergo the translumbar procedure; AND
• Being older than 18 years

Ki nem vehet részt

• 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
• Patient with haemostatic disorder (including bleeding disorders) or who is clinically unstable; OR
• Patient who is allergic to contrast media or anticoagulants; OR
• Patient with renal impairment (eGFR < 30 ml/min); OR
• Patient not able or willing to give written Informed Consent; OR
• Patient undergoing emergency procedures; OR
• Patient with traumatic vascular injury; OR
• Patient with a too high risk of abdominal sac rupture to allow safe radiological and scanographic assessments; OR
• Patient with a contra-indication for temporal positioning of a translumbar needle/catheter; OR
• Pre-menopausal women, OR
• Patient with a life expectancy of less than 12 months, OR
• Patient with an intra aneurysm systolic blood pressure > 125 mmHg