CompletedNot Applicable

ANEUFIX for Endoleaks Type II

Netherlands4 participantsStarted 2018-02-26

Plain-language summary

The study is a non-randomized, multi-center safety and feasibility trial of Aneufix ACP-T5 to treat patients with Isolated type II endoleak in the presence of a non-shrinking AAA sac following an EVAR procedure.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Persistent type IIa or IIb endoleak (more than 6 months post-EVAR or post-embolization procedure); AND
✓. Volume of the 'endoleak void' can be determined upfront; AND
✓. An EVAR without circulatory complications; AND
✓. An endoleak confirmed by CT scan in preceding 6 weeks demonstrating the high likelihood of the isolated nature of the endoleak; AND
✓. An aneurysm sac growing in contours after EVAR (per European Guidelines) as documented in the preceding 6 weeks by means of echo (or alternative visualization technique); AND
✓. An aneurysm sac that can be punctured in translumbar approach ; AND
✓. Possibility to withhold anti-thrombogenic medication temporarily; AND
✓. Ability and willingness to undergo the translumbar procedure under local anesthesia in a CT scan; AND

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 hemostatic disorder or who is clinically unstable; OR
✕. Patient with a too high risk of abdominal sac rupture to allow safe radiological and scanographic assessments; OR
✕. Patient who is allergic to contrast media or anticoagulants; OR
✕. Patient with renal impairment (serum creatinine \> 2 mg/dl or \> 176 mmol/l); OR
✕. Patient who is participating in another trial with an investigational drug or medical device; OR

What they're measuring

Technical success of Type II endoleak repair with Aneufix ACP-T5 as demonstrated by the absence of an endoleak at the end of the procedure.

Timeframe: 24h

Trial details

NCT IDNCT02487290

SponsorTripleMed B.V.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-02-01

View on ClinicalTrials.gov More Abdominal Aortic Aneurysm trials