Abdominal Aortic AneurysmNCT03918460
ANEUFIX for Endoleak Type II Repair
A study testing ANEUFIX in people with Abdominal Aortic Aneurysm and Endoleak, run by TripleMed B.V. at 9 sites in 2 countries.
Trial summary
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. 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?
- ANEUFIX
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 13 May 2020to 24 Mar 2028
- 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
- Persistent type II endoleak (more than 6 months post-EVAR or post-embolization procedure); AND
- An endoleak confirmed on a CT scan that should be done within 180 days prior to procedure but preferably within 90 days prior to screening demonstrating the high likelihood of the isolated nature of the endoleak; AND
- An aneurysm sac growing after EVAR of minimal 10 mm (per European Guidelines) as documented in the preceding 90 days by means of CT-imaging (or alternative imaging techniques) and based upon sac diameter measurements; AND
- An aneurysm sac that can be punctured via a translumbar approach; AND
- Possibility to withhold anti-thrombogenic medication temporarily; AND
- Ability and willingness to undergo the translumbar procedure; AND
- Being older than 18 years.
Who cannot join
- Patient not able or willing to give written Informed Consent; OR
- Patient undergoing emergency procedures; OR
- Patient with traumatic vascular injury; OR
- Patient with haemostatic disorder (including bleeding disorders) or who is clinically unstable; OR
- Patient with a too high risk of abdominal sac rupture to allow safe radiological and scanographic assessments; OR
- Patient who is allergic to contrast media or anticoagulants; OR
Show all 12Show fewer
- Patient with renal impairment (eGFR < 30 ml/min); OR
- Patient with a contra-indication for temporal positioning of a translumbar needle/catheter; OR
- Patient who is participating in another trial with an investigational drug or medical device, or where a medical device/drug is used outside its labelling and its approved intended use; OR
- Pre-menopausal women, OR
- Patient with a life expectancy of less than 12 months, OR
- Patient with an intra aneurysm systolic blood pressure > 125 mmHg
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Netherlands6 sites
ZGT
Almelo
Amsterdam UMC - VUmc
Amsterdam
OLVG
Amsterdam
Rijnstate
Arnhem
Spaarne Gasthuis
Haarlem
ETZ
Tilburg
About this study
Official title: Treatment of Type II Endoleak With ANEUFIX: Assessment of Safety, Performance and Clinical Benefit.
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.
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
- 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.
ANEUFIXDevice
ANEUFIX is administered through translumbar injection into the AAA using imaging techniques to guide the place of injection.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | All patients enrolled are intended to be treated Receives: Device: ANEUFIX |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (7)
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.
Measured: 6, 12 and 14 months
Intra- and peri-operative complications
Documentation of intra- and peri-operative complications
Measured: 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.
Measured: 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
Measured: 1 week and 1, 6, 12 and 24 months
Rate of re-interventions
Rate of secondary endovascular or surgical re-interventions
Measured: 1, 6, 12 and 24 months
Rate of aneurysm rupture
Rate of aneurysm rupture will be observed
Measured: 6,12 and 24 months
Survival rate
Survival throughout the study
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 posted17 Apr 2019
- Study start13 May 2020
- Primary completion24 Sep 2026
- Study completion24 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 evaluates the end-points in a total of 40 patients.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TripleMed B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Trium Clinical Consulting
- Responsible party
- Sponsor
- Investigators
- Arjan WJ Hoksbergen, Dr, Principal investigator, VUmc Heelkunde, Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03918460
- Sponsor's protocol ID
- TripleMed 002
- Status last verified
- Oct 2026
- First submitted
- 12 Apr 2019
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- Treatment of Type II Endoleak With ANEUFIX: Assessment of Safety, Performance and Clinical Benefit.
- ClinicalTrials.gov ID
- NCT03918460
- Acronym / sponsor ID
- TripleMed 002
- Conditions
- Abdominal Aortic Aneurysm, Endoleak
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- TripleMed B.V.Industry (pharma, biotech, devices)
- Collaborators
- Trium Clinical Consulting
- Study start
- 13 May 2020 (actual)
- Primary completion
- 24 Sep 2026 (actual)
- Study completion
- 24 Mar 2028 (estimated)
- First posted
- 17 Apr 2019 (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.
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.
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 evaluates the end-points in a total of 40 patients.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: ANEUFIXAll patients enrolled are intended to be treated |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Persistent type II endoleak (more than 6 months post-EVAR or post-embolization procedure); AND
- An endoleak confirmed on a CT scan that should be done within 180 days prior to procedure but preferably within 90 days prior to screening demonstrating the high likelihood of the isolated nature of the endoleak; AND
- An aneurysm sac growing after EVAR of minimal 10 mm (per European Guidelines) as documented in the preceding 90 days by means of CT-imaging (or alternative imaging techniques) and based upon sac diameter measurements; AND
- An aneurysm sac that can be punctured via a translumbar approach; AND
- Possibility to withhold anti-thrombogenic medication temporarily; AND
Key exclusion criteria (12 listed)
- Patient not able or willing to give written Informed Consent; OR
- Patient undergoing emergency procedures; OR
- Patient with traumatic vascular injury; OR
- Patient with haemostatic disorder (including bleeding disorders) or who is clinically unstable; OR
- Patient with a too high risk of abdominal sac rupture to allow safe radiological and scanographic assessments; OR
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 |
|---|---|---|
| ANEUFIXANEUFIX is administered through translumbar injection into the AAA using imaging techniques to guide the place of injection. | Device | Intervention |
Primary outcome
Technical success rate
Time frame: 24 hours
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.
7 secondary outcomes
Absence of aneurysm sac growth
Time frame: 6, 12 and 14 months
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
Time frame: During the Aneufix procedure
Occurrence of general adverse events and adverse device effects
Time frame: 1 week and 1, 6, 12 and 24 months
Rate of re-interventions
Time frame: 1, 6, 12 and 24 months
Rate of aneurysm rupture
Time frame: 6,12 and 24 months
Survival rate
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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Arjan WJ Hoksbergen, Dr principal investigator
VUmc Heelkunde, Amsterdam
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ANEUFIX in people with Abdominal Aortic Aneurysm and Endoleak, run by TripleMed B.V. at 9 sites in 2 countries.
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 7 inclusion and 12 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: under way, not looking for participants, 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 9 sites in Netherlands, Belgium. 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 rate (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.