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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
ANEUFIX is administered through translumbar injection into the AAA using imaging techniques to guide the place of injection.
Imelda
Bonheiden, Belgium
RECRUITINGZOL
Genk, Belgium
RECRUITINGUZ Leuven
Leuven, Belgium
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.
Time frame: 24 hours
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.
Time frame: 6, 12 and 14 months
Intra- and peri-operative complications
Documentation of intra- and peri-operative complications
Time frame: 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.
Time frame: 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
Time frame: 1 week and 1, 6, 12 and 24 months
Rate of re-interventions
Rate of secondary endovascular or surgical re-interventions
Time frame: 1, 6, 12 and 24 months
Rate of aneurysm rupture
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ZGT
Almelo, Netherlands
ACTIVE_NOT_RECRUITINGAmsterdam UMC - VUmc
Amsterdam, Netherlands
ACTIVE_NOT_RECRUITINGOLVG
Amsterdam, Netherlands
TERMINATEDRijnstate
Arnhem, Netherlands
TERMINATEDSpaarne Gasthuis
Haarlem, Netherlands
ACTIVE_NOT_RECRUITINGETZ
Tilburg, Netherlands
ACTIVE_NOT_RECRUITINGRate of aneurysm rupture will be observed
Time frame: 6,12 and 24 months
Survival rate
Survival throughout the study
Time frame: 24 months