Clinical Research Directory

Inclusion Criteria: 1. Persistent type II endoleak (more than 6 months post-EVAR or post-embolization procedure); AND 2. 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 3. 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 4. An aneurysm sac that can be punctured via a translumbar approach; AND 5. Possibility to withhold anti-thrombogenic medication temporarily; AND 6. Ability and willingness to undergo the translumbar procedure; AND 7. Being older than 18 years. Exclusion Criteria: 1. Patient not able or willing to give written Informed Consent; OR 2. Patient undergoing emergency procedures; OR 3. Patient with traumatic vascular injury; OR 4. Patient with haemostatic disorder (including bleeding disorders) or who is clinically unstable; OR 5. Patient with a too high risk of abdominal sac rupture to allow safe radiological and scanographic assessments; OR 6. Patient who is allergic to contrast media or anticoagulants; OR 7. Patient with renal impairment (eGFR \< 30 ml/min); OR 8. Patient with a contra-indication for temporal positioning of a translumbar needle/catheter; OR 9. 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 10. Pre-menopausal women, OR 11. Patient with a life expectancy of less than 12 months, OR 12. Patient with an intra aneurysm systolic blood pressure \> 125 mmHg