ANEUFIX for Endoleak Type II Repair

This is an interventional treatment trial for Abdominal Aortic Aneurysm Read More

Inclusion Criteria:

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 EVAR without circulatory complications (including the absence of an open AMI that is connected to the endoleak as judged on existing CT-scan); AND
4. 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
5. An aneurysm sac growing in contours after EVAR of minimal 10 mm (per European Guidelines) as documented in the preceding 90 days by means of Echo Doppler (or alternative visualization technique) and based upon sac diameter measurements; AND
6. An aneurysm sac that can be punctured via a translumbar approach; AND
7. Possibility to withhold anti-thrombogenic medication temporarily; AND
8. Ability and willingness to undergo the translumbar procedure under local anesthaesia in a CT scanner; AND
9. 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. Patients with an untreated open endoleak connected AMI (patients can be included if the AMI is coild or is technically not possible to be coiled prior the Aneufix application); OR
5. Patient with haemostatic 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 (eGFR < 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. Women of child-bearing potential, OR
12. Patient with a life expectancy of less than 12 months.