ClinicalTrials.gg
Sign In
Enrolling by invitationNCT04307992Updated Oct 22, 2026

AneuFix - Prophylactic Sac Filling

An interventional study of Prophylactic sac filling with AneuFix in Abdominal Aortic Aneurysm and Endoleak, sponsored by TripleMed B.V.. Enrolling by invitation at 3 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by TripleMed B.V. · Not applicable, Interventional, and Treatment

Updated Oct 22, 2026Now Enrolling by invitationPrimary completion moved+5 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Abdominal Aortic Aneurysm
  • Endoleak
03

In context

Aortic Aneurysm, Abdominal

467 studies on the registry are indexed under Aortic Aneurysm, Abdominal; 99 are open to participants now.

This study's planned enrollment of 20 is below the median of 66 across 228 interventional studies indexed under Aortic Aneurysm, Abdominal.

Browse Aortic Aneurysm, Abdominal studies →

Lead sponsor

TripleMed B.V. is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Oct 22, 2026. See what changed

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Patient not able or willing to give written
  • 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
  • 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
  • Patients with evidence at completion angiogram during EVAR of a type Ia or type III endoleak persistent after balloon inflation
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Intervention

    Device: ANEUFIX

    Device: Prophylactic sac filling with AneuFix

Interventions

  • DeviceProphylactic sac filling with AneuFix

    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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 24 hours

  2. 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

  3. 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

Secondary outcomes

  1. Intraoperative occurrence of complications

    Adverse events occurring during the surgical intervention are registered.

    Time frame: 24 hours

  2. Peri-operative complications

    Rate of peri-operative complications

    Time frame: 30 days

  3. Prevention of (any type of) endoleak

    Occurrence of (any type of) endoleak

    Time frame: 1, 6 and 12 months

  4. adverse events

    Occurrence of adverse events and adverse device effects

    Time frame: 1, 6 and 12 months

  5. Re-interventions

    Rate of secondary endovascular or surgical re-interventions

    Time frame: 1, 6 and 12 months

  6. Aneurysm rupture

    Rate of aneurysm rupture

    Time frame: 6 and 12 months

  7. Proportion of patients surviving 24 months after treatment

    Survival throughout the study up until 24 months

    Time frame: 24 months

07

Study locations

3 sites
08

References and documents

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 ↗
09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2022 (actual). Primary completion is estimated for Nov 2026, 57 months after the start.

Of 43 industry-sponsored interventional studies with no phase under Aortic Aneurysm, Abdominal, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 65. This study's planned 57 months is above that.

Counting every sponsor, half of 94 studies reached it within 43 months; a quarter within 23 and three quarters within 65.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 22, 2026: primary completion Dec 2025 → Nov 2026 and completion Dec 2025 → Nov 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Mar 10, 2020
First posted
Mar 13, 2020
StartActual
Feb 15, 2022
Primary completionEst.
Nov 30, 2026was Dec 2025
CompletionEst.
Nov 30, 2027was Dec 2025
Last update
Oct 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Enrolling by invitation
changed Oct 22, 2026
Sites
3 sites added, 1 site removed
Show 3 added (3 Netherlands)
  • VUmc · Amsterdam, Netherlands
  • Spaarne Gasthuis Haarlem · Haarlem, Netherlands
  • ZGT Almelo · Almelo, Netherlands
Show 1 removed
  • VUmc · Amsterdam, Netherlands
Oct 22, 2026
Primary completion
Dec 31, 2025→Nov 30, 2026
Oct 22, 2026
Study completion
Dec 31, 2025→Nov 30, 2027
Oct 22, 2026
Enrollment
5→20
Oct 22, 2026
Eligibility
1 inclusion criterion edited, 2 added, 6 removed
What changed in the criteria
Inclusion criteria
  • EditedAsymptomatic, infrarenal AAA that requires surgery with a high-risk profile of developing endoleak type II in line with the recommendations of GuntnerFabre et al:v
  • RemovedOpen IMA AND
  • Removed1 patent lumbar AND a cross-sectional area at the location of the IMA (CSAIMA) >17,5cm2 OR
  • Removed2 patent lumbars AND a CSAIMA >15cm2 OR
  • Removed3 patent lumbars AND a CSAIMA >12,5 cm2 OR
  • Removed4 patent lumbars AND a CSAIMA >10 cm2 OR
  • Removed5 patent lumbars AND a CSAIMA >7,5 cm2
  • Addeda patent IMA, with a luminal diameter at its origin > 3 mm, OR
  • Addedat least three pairs of patent lumbar arteries, or two pairs of lumbar arteries and a median sacral artery or an accessory renal artery.
Oct 22, 2026
Publications
2 publications citing this study linked from PubMed, e.g. PubMed 41475431 ↗
Oct 22, 2026
Contact
No study contact listed any more: removed f•••@triple-med.com · •••9291; removed t•••@triple-med.com · •••8003
Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    Recruiting→Enrolling by invitation
    Publications 2 publications citing this study linked from PubMed, e.g. PubMed 41475431 ↗
    3 sites added, 1 site removed
    Show 3 added (3 Netherlands)
    • VUmc · Amsterdam, Netherlands
    • Spaarne Gasthuis Haarlem · Haarlem, Netherlands
    • ZGT Almelo · Almelo, Netherlands
    Show 1 removed
    • VUmc · Amsterdam, Netherlands
    Primary completion Dec 31, 2025→Nov 30, 2026
    Study completion Dec 31, 2025→Nov 30, 2027
    Enrollment 5→20
    Eligibility 1 inclusion criterion edited, 2 added, 6 removed
    What changed in the criteria
    Inclusion criteria
    • EditedAsymptomatic, infrarenal AAA that requires surgery with a high-risk profile of developing endoleak type II in line with the recommendations of GuntnerFabre et al:v
    • RemovedOpen IMA AND
    • Removed1 patent lumbar AND a cross-sectional area at the location of the IMA (CSAIMA) >17,5cm2 OR
    • Removed2 patent lumbars AND a CSAIMA >15cm2 OR
    • Removed3 patent lumbars AND a CSAIMA >12,5 cm2 OR
    • Removed4 patent lumbars AND a CSAIMA >10 cm2 OR
    • Removed5 patent lumbars AND a CSAIMA >7,5 cm2
    • Addeda patent IMA, with a luminal diameter at its origin > 3 mm, OR
    • Addedat least three pairs of patent lumbar arteries, or two pairs of lumbar arteries and a median sacral artery or an accessory renal artery.
    Contact No study contact listed any more: removed f•••@triple-med.com · •••9291; removed t•••@triple-med.com · •••8003
    + 3 other changes: verification date, design details and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT04307992
Lead sponsor
TripleMed B.V.
Responsible party
Sponsor
First posted
Mar 13, 2020
Start date
Feb 15, 2022
Primary completion
Nov 30, 2026 (estimated)
Completion
Nov 30, 2027 (estimated)
Last update
Oct 22, 2026

Study contacts

Arjan WJ Hoksbergen, Dr
principal investigator · VUmc Heelkunde, Amsterdam

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Aortic Aneurysm, Abdominal →

Other studies from this sponsor

TripleMed B.V.

Start the discussion