This study is set up to assess the feasibility and safety of the clinical procedure using AneuFix in a prophylactic setting at the time of EVAR endograft implantation.
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
5
ANEUFIX is administered by injection into the AAA via transferal access at the time of EVAR placement using imaging techniques to guide the place of injection.
VUmc
Amsterdam, North Holland, Netherlands
RECRUITINGTechnical Success
Technical Success as demonstrated by the feasibility to fill the AAA sac after EVAR during the same procedure, and by the rate of (all) endoleaks after EVAR followed by the AneuFix procedure
Time frame: 24 hours
Clinical Success rate
Clinical Success as demonstrated by the occurrence of type II endoleaks at 6 months after EVAR, and aneurysmal sac growth at 6 months after EVAR
Time frame: 6 months
Clinical Success rate
Clinical Success as demonstrated by the occurrence of type II endoleaks at 12 months after EVAR, and aneurysmal sac growth at 12 months after EVAR
Time frame: 12 months
Intraoperative occurrence of complications
Adverse events occurring during the surgical intervention are registered.
Time frame: 24 hours
Peri-operative complications
Rate of peri-operative complications
Time frame: 30 days
Prevention of (any type of) endoleak
Occurrence of (any type of) endoleak
Time frame: 1, 6 and 12 months
adverse events
Occurrence of adverse events and adverse device effects
Time frame: 1, 6 and 12 months
Re-interventions
Rate of secondary endovascular or surgical re-interventions
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Time frame: 1, 6 and 12 months
Aneurysm rupture
Rate of aneurysm rupture
Time frame: 6 and 12 months
Proportion of patients surviving 24 months after treatment
Survival throughout the study up until 24 months
Time frame: 24 months