Clinical trial NCT03918460: ANEUFIX for Endoleak Type II Repair
Official title: Treatment of Type II Endoleak With ANEUFIX: Assessment of Safety, Performance and Clinical Benefit.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Abdominal Aortic Aneurysm
Endoleak
Lead sponsor: TripleMed B.V.
Sponsor class: INDUSTRY
Collaborators: name: Trium Clinical Consulting
First posted: 2019-04-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

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

Primary outcomes:
measure: Technical success rate
timeFrame: 24 hours
Secondary outcomes:
measure: Absence of aneurysm sac growth
timeFrame: 6, 12 and 14 months
measure: Intra- and peri-operative complications
timeFrame: 30 days
measure: serious adverse events, vascular related adverse events and adverse device effects: complications and deaths, re-interventions, aneurysm rupture
timeFrame: During the Aneufix procedure
measure: Occurrence of general adverse events and adverse device effects
timeFrame: 1 week and 1, 6, 12 and 24 months
measure: Rate of re-interventions
timeFrame: 1, 6, 12 and 24 months
measure: Rate of aneurysm rupture
timeFrame: 6,12 and 24 months
measure: Survival rate
timeFrame: 24 months
Other outcomes:
Locations:
city: Bonheiden
country: Belgium
facility: Imelda
city: Genk
country: Belgium
facility: ZOL
city: Leuven
country: Belgium
facility: UZ Leuven
city: Almelo
country: Netherlands
facility: ZGT
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC - VUmc
city: Amsterdam
country: Netherlands
facility: OLVG
city: Arnhem
country: Netherlands
facility: Rijnstate
city: Haarlem
country: Netherlands
facility: Spaarne Gasthuis
city: Tilburg
country: Netherlands
facility: ETZ
Study officials:
affiliation: VUmc Heelkunde, Amsterdam
name: Arjan WJ Hoksbergen, Dr
role: PRINCIPAL_INVESTIGATOR
References: