The study is non-randomized, multicenter international safety, performance and clinical benefit outcome assessment of ANEUFIX to treat patients with isolated type II endoleak in the presence of a growing AAA-sac following an EVAR procedure more than 6 months ago.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
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 haemostatic disorder (including bleeding disorders) or who is clinically unstable; OR
✕. Patient with a too high risk of abdominal sac rupture to allow safe radiological and scanographic assessments; OR