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.
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
- Are there results?
- Not yet: the study is under way
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
Show all 17Show fewer
- 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
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- TripleMed B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arjan WJ Hoksbergen, Dr, Principal investigator, VUmc Heelkunde, Amsterdam
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 41475431Smorenburg 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Assessment of the Prophylactic Use of AneuFix at the Time of EVAR Implantation
- ClinicalTrials.gov ID
- NCT04307992
- Acronym / sponsor ID
- Triplemed 003
- Conditions
- Abdominal Aortic Aneurysm, Endoleak
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- TripleMed B.V.Industry (pharma, biotech, devices)
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 13 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Prophylactic sac filling with AneuFixDevice: ANEUFIX |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- 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
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prophylactic sac filling with AneuFixANEUFIX 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. | Device | Intervention |
Primary outcome
Technical Success
Time frame: 24 hours
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
Clinical Success rate
Time frame: 6 months
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
Clinical Success rate
Time frame: 12 months
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
7 secondary outcomes
Intraoperative occurrence of complications
Time frame: 24 hours
Peri-operative complications
Time frame: 30 days
Prevention of (any type of) endoleak
Time frame: 1, 6 and 12 months
adverse events
Time frame: 1, 6 and 12 months
Re-interventions
Time frame: 1, 6 and 12 months
Aneurysm rupture
Time frame: 6 and 12 months
Proportion of patients surviving 24 months after treatment
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Derived from this study: PubMed 41475431Smorenburg 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.
- Derived from this study: PubMed 39009453Smorenburg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arjan WJ Hoksbergen, Dr principal investigator
VUmc Heelkunde, Amsterdam
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical Success (time frame: 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04307992, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.