Treatment of Type II Endoleak With ANEUFIX: Assessment of Safety, Performance and Clinical Benefit.
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.
• 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.