Abdominal Aortic AneurysmNCT04307992

AneuFix - Prophylactic Sac Filling

A study testing Prophylactic sac filling with AneuFix in people with Abdominal Aortic Aneurysm and Endoleak, run by TripleMed B.V. at 3 sites in Netherlands.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Abdominal Aortic Aneurysm, Endoleak
What is being tested?: Prophylactic sac filling with AneuFix
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 3 sitesNetherlands
Study dates: 15 Feb 2022to 30 Nov 2027
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Asymptomatic, infrarenal AAA that requires surgery with a high-risk profile of developing endoleak type II in line with the recommendations of Fabre et al:v
a patent IMA, with a luminal diameter at its origin > 3 mm, OR
at least three pairs of patent lumbar arteries, or two pairs of lumbar arteries and a median sacral artery or an accessory renal artery.
Infrarenal neck according to the IFU of the EVAR device
Other aortic-iliac anatomical configuration suitable for EVAR according to the criteria of the EVAR device to be used
Patient having a life expectation of at least 2 years
Being older than 18 years
Willing and able to comply with the requirements of this clinical study

Who cannot join

Patient not able or willing to give written Informed Consent
Patient undergoing emergency procedures
Patient undergoing EVAR for ruptured or symptomatic AAA,
Patient with a suprarenal AAA
Patient with an inflammatory AAA (more than minimal wall thickening)
Patient with an infrarenal neck unsuitable for endovascular fixation (including so called "hostile necks") or aortic-iliac anatomic configuration otherwise unsuitable for EVAR according to criteria of the device to be used

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Patient in which a bilateral retroperitoneal incision is required for EVAR
Patient in which a sacrifice of both hypogastric arteries is required
Patient with anatomical variations, i.e. horseshoe-kidney, arteries requiring reimplantation
Patient in which the administration of contrast agent is not possible: proved, severe systemic reaction to contrast agent
Patient with active infection present
Patients scheduled for or having received an organ transplant
Patient with limited life expectation due to other illness (<1 year)
Patient with non-iatrogenic bleeding diathesis
Patient with connective tissue disease
Women of child-bearing potential
Patients with evidence at completion angiogram during EVAR of a type Ia or type III endoleak persistent after balloon inflation

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Netherlands3 sites

ZGT Almelo
Almelo, Overijssel, 7609 PP
VUmc
Amsterdam, North Holland, 1081 HV
Spaarne Gasthuis Haarlem
Haarlem, North Holland

Other trials in Netherlands

About this study

Official title: Feasibility Assessment of the Prophylactic Use of AneuFix at the Time of EVAR Implantation

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.

Read the 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.

Conditions: Abdominal Aortic Aneurysm, Endoleak
Being tested: Prophylactic sac filling with AneuFix
Medical subject headings: Aortic Aneurysm, Abdominal, Endoleak

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Prophylactic sac filling with AneuFixDevice
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.

Study groups in NCT04307992
Study group	Role	What they receive
Intervention	Experimental	Device: ANEUFIX Receives: Device: Prophylactic sac filling with AneuFix

What is being measured

The primary outcome is the main question the study is designed to answer.

Technical 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
Measured: 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
Measured: 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
Measured: 12 months

Secondary outcomes (7)

Intraoperative occurrence of complications
Adverse events occurring during the surgical intervention are registered.
Measured: 24 hours
Peri-operative complications
Rate of peri-operative complications
Measured: 30 days
Prevention of (any type of) endoleak
Occurrence of (any type of) endoleak
Measured: 1, 6 and 12 months
adverse events
Occurrence of adverse events and adverse device effects
Measured: 1, 6 and 12 months
Re-interventions
Rate of secondary endovascular or surgical re-interventions
Measured: 1, 6 and 12 months
Aneurysm rupture
Rate of aneurysm rupture
Measured: 6 and 12 months
Proportion of patients surviving 24 months after treatment
Survival throughout the study up until 24 months
Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Feb 202230 Nov 2027

First posted13 Mar 2020
Study start15 Feb 2022
Primary completion30 Nov 2026 (estimated)
Study completion30 Nov 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
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 is a pilot study that (1) evaluates the technical feasibility of the prophylactic use of AneuFix during EVAR implentation and (2) assesses the rate of endoleaks after EVAR in 5 patients. The study was amended to treat another 10 patients with polymer of less radiopacity and updated inclusion criteria and 2 additional sites in 2024 and again in 2026 to treat another 5 patients with the final protocol and polymer design.
Masking: None (open label)
Enrolment: 20 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04307992
Sponsor's protocol ID: Triplemed 003
Status last verified: Oct 2026
First submitted: 10 Mar 2020
Last updated: 22 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Smorenburg SPM, Lely RJ, Jongkind V, Groeneveld ME, de Vries AC, Brom HLF, Jacobs MJ, Hoksbergen AWJ. First in Human Aortic Aneurysm Sac Filling with AneuFix Injectable Polymer during Endovascular Aneurysm Repair. Eur J Vasc Endovasc Surg. 2025 Dec 29:S1078-5884(25)01317-6. doi: 10.1016/j.ejvs.2025.12.048. Online ahead of print.
PubMed 41475431
Smorenburg SPM, Lely RJ, Jacobs MJ, Hoksbergen AWJ. Aortic aneurysm sac filling with AneuFix injectable polymer during endovascular aneurysm repair: feasibility and safety trial study protocol. BMJ Open. 2024 Jul 15;14(7):e082380. doi: 10.1136/bmjopen-2023-082380.
PubMed 39009453

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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