Ireland
--:--IST
Active, not recruiting Not applicable

ANEUFIX for Endoleak Type II Repair

NCT03918460 · tracked via the Priya Life Science Belgium tracker
Phase
Not applicable
Started
2020-05-13
Last updated
2026-10-22

Condition(s) studied

Abdominal Aortic AneurysmEndoleak

Investigational drug(s) / intervention(s)

ANEUFIX

ANEUFIX: ANEUFIX is administered through translumbar injection into the AAA using imaging techniques to guide the place of injection.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Technical success rate — 24 hours
    Technical success of Type II endoleak repair with Aneufix as demonstrated by the absence of endoleak circulation at the intended treated endoleak at the end of the procedure; presence or absence of the endoleak treated with ANEUFIX is verified by means of a CT scan the next day.

Trial sites (9)

FacilityCityRegionStatus
Imelda Bonheiden Belgium
ZOL Genk Belgium
UZ Leuven Leuven Belgium
ZGT Almelo Netherlands
Amsterdam UMC - VUmc Amsterdam Netherlands
OLVG Amsterdam Netherlands
Rijnstate Arnhem Netherlands
Spaarne Gasthuis Haarlem Netherlands
ETZ Tilburg Netherlands

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03918460 on ClinicalTrials.gov ↗ ← All trials in Belgium