ANEUFIX for Endoleak Type II Repair

Study Overview
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Brief Summary
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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.

Detailed Description
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The investigational device is called ANEUFIX, which is a product treating the endoleak by blockage of backflowing blood vessels, i.e. by filling the endoleak void and nidus of feeding artery and exit of existing draining arteries. ANEUFIX is a polymer that cures rapidly (2-4 min at 37°C) after injection into the AAA-sac close to the nidus.

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

Conditions
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Abdominal Aortic Aneurysm, Endoleak

Intervention / Treatment
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* Device: ANEUFIX


Participation Criteria
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Eligibility Criteria
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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 Patient who is allergic to contrast media or anticoagulants; OR Patient with renal impairment (eGFR < 30 ml/min); OR Patient with a contra-indication for temporal positioning of a translumbar needle/catheter; OR 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 Pre-menopausal women, OR Patient with a life expectancy of less than 12 months, OR Patient with an intra aneurysm systolic blood pressure > 125 mmHg

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: The current study is a follow up study on the previous feasibility study where ACP-T5 was used; after increasing the % tantalum in ANEUFIX to make the product more detectable under X-ray, the current study evaluates the end-points in a total of 40 patients.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>All patients enrolled are intended to be treated | Device: ANEUFIX<br>* ANEUFIX is administered through translumbar injection into the AAA using imaging techniques to guide the place of injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success rate | 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. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of aneurysm sac growth | Absence of aneurysm sac growth at 6, 12 and 24 months. Growth is determined based on independent core lab assessments of the abdominal aortic diameter, measured as the maximum diameter relative to the aneurysm. | 6, 12 and 14 months | 
| Intra- and peri-operative complications | Documentation of intra- and peri-operative complications | 30 days | 
| serious adverse events, vascular related adverse events and adverse device effects: complications and deaths, re-interventions, aneurysm rupture | Occurrence of serious adverse events, vascular related adverse events and adverse device effects: complications and deaths, re-interventions, aneurysm rupture in the peri operative period. | During the Aneufix procedure | 
| Occurrence of general adverse events and adverse device effects | Safety is assessed based on the nature and severity of observed adverse events | 1 week and 1, 6, 12 and 24 months | 
| Rate of re-interventions | Rate of secondary endovascular or surgical re-interventions | 1, 6, 12 and 24 months | 
| Rate of aneurysm rupture | Rate of aneurysm rupture will be observed | 6,12 and 24 months | 
| Survival rate | Survival throughout the study | 24 months |