Treatment of type II endoleak using ANEUFIX

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

This study is testing a new treatment called ANEUFIX to see if it can safely fix type II endoleaks in patients with a growing abdominal aortic aneurysm after they've had surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: TripleMed B.V. (Industry-sponsored)
• Locations: 9 sites (Bonheiden and 8 other locations)
• Trial ID: NCT03918460 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of ANEUFIX, a polymer designed to treat isolated type II endoleaks in patients with a growing abdominal aortic aneurysm (AAA) sac following an endovascular aneurysm repair (EVAR) procedure. The study is non-randomized and multicenter, focusing on patients who have had persistent endoleaks for over six months. ANEUFIX works by blocking backflowing blood vessels, filling the endoleak void, and addressing the feeding and draining arteries. Participants will undergo a translumbar procedure to administer the treatment.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with persistent type II endoleaks confirmed by CT scan and growing aneurysm sacs post-EVAR.

Not a fit: Patients who are undergoing emergency procedures or have traumatic vascular injuries may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for patients with type II endoleaks and growing AAA sacs.

How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, indicating that this may be a novel intervention.

Eligibility criteria

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

Where this trial is running

Bonheiden and 8 other locations

• Imelda — Bonheiden, Belgium (Recruiting)
• Zol — Genk, Belgium (Recruiting)
• UZ Leuven — Leuven, Belgium (Recruiting)
• Zgt — Almelo, Netherlands (Active_not_recruiting)
• Amsterdam UMC - VUmc — Amsterdam, Netherlands (Active_not_recruiting)
• Olvg — Amsterdam, Netherlands (Terminated)
• Rijnstate — Arnhem, Netherlands (Terminated)
• Spaarne Gasthuis — Haarlem, Netherlands (Active_not_recruiting)
• Etz — Tilburg, Netherlands (Active_not_recruiting)

Study contacts

• Principal investigator: Arjan WJ Hoksbergen, Dr — VUmc Heelkunde, Amsterdam
• Study coordinator: Tjeerd Homsma

Conditions Abdominal Aortic Aneurysm; Endoleak