Abdominal Aortic AneurysmACP-T5NCT02487290
ANEUFIX for Endoleaks Type II
A study testing Aneufix ACP-T5 in people with Abdominal Aortic Aneurysm, run by TripleMed B.V. at 2 sites in Netherlands.
Trial summary
The study is a non-randomized, multi-center safety and feasibility trial of Aneufix ACP-T5 to treat patients with Isolated type II endoleak in the presence of a non-shrinking AAA sac following an EVAR procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- Aneufix ACP-T5
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesNetherlands
- Study dates
- 26 Feb 2018to 15 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 IIa or IIb endoleak (more than 6 months post-EVAR or post-embolization procedure); AND
- Volume of the 'endoleak void' can be determined upfront; AND
- An EVAR without circulatory complications; AND
- An endoleak confirmed by CT scan in preceding 6 weeks demonstrating the high likelihood of the isolated nature of the endoleak; AND
- An aneurysm sac growing in contours after EVAR (per European Guidelines) as documented in the preceding 6 weeks by means of echo (or alternative visualization technique); AND
- An aneurysm sac that can be punctured in translumbar approach ; AND
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- Possibility to withhold anti-thrombogenic medication temporarily; AND
- Ability and willingness to undergo the translumbar procedure under local anesthesia in a CT scan; AND
- Be 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 hemostatic disorder 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
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- Patient with renal impairment (serum creatinine > 2 mg/dl or > 176 mmol/l); OR
- Patient who is participating in another trial with an investigational drug or medical device; OR
- Women of child-bearing potential; OR
- Patient with a life expectancy of less than 12 months.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Spaarne Gasthuisberg
Haarlem, 2035 RC
Medisch Centrum Westeinde
The Hague, 2512
About this study
Official title: Feasibility Study of Treatment Type II Endoleaks With ACP-T5: a Novel Approach.
The study is a non-randomized, multi-center safety and feasibility trial of Aneufix ACP-T5 to treat patients with Isolated type II endoleak in the presence of a non-shrinking AAA sac following an EVAR procedure.
Read the detailed description
The investigational device is called Aneufix, more specifically the model ACP-T5, 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'.
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- Aneufix ACP-T5
- Keywords
- AAA, Endoleak
- 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.
Aneufix ACP-T5Device
Also called ANEUFIX
The ACP-T5 is injected via translumbar approach into the aneurysm sac near the entrance/exit of bloodvessel. ACP-T5 will cure and block the endoleak.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Aneufix ACP-T5 Receives: Device: Aneufix ACP-T5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success of Type II endoleak repair with Aneufix ACP-T5 as demonstrated by the absence of an endoleak at the end of the procedure.
At the end of the injection procedure, the technical success will be determined by angiographic recording and physician assessment of absence of endoleak. CT scan at 24 hrs is obtained to reconfirm the absence of endoleak.
Measured: 24h
Secondary outcomes (6)
Clinical succes rate.
The clinical succes rate is defined as the absence of aneurysm sac growth after the procedure of ACP-T5 injection.
Measured: 6 and 12 months
Safety aspects I : intra-operative complication rate.
Intra-operative occurrence of complications.
Measured: All complications observed during the ACP-T5 injection procedure are documented.
Safety aspects II: Peri-operative complication rate.
All complications as well as the occurrence of adverse events and adverse device effects during the period of 24 hrs - 1 month are observed, documented, adjudicated and reported. adverse device effects are observed, documented, adjudicated and reported.
Measured: 1 month
Safety aspects III : Mid- and long-term complication rate.
All complications as well as the occurrence of adverse events and adverse device effects during the period of 1-12 months are observed, documented, adjudicated and reported. adverse device effects are observed, documented, adjudicated and reported.
Measured: 1-12 months
Aneurysm sac rupture.
The aneurysm sac rupture rate is assessed over a period of 12 months.
Measured: 12 months
Survival.
The survival rate throughout the study and up to 24 months is assessed.
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 posted1 Jul 2015 (estimated)
- Study start26 Feb 2018
- Primary completion1 Feb 2019
- Study completion15 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a feasibility study, where initially 5 patients are to be treated.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- TripleMed B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fakkel bvba
- Responsible party
- Sponsor
- Investigators
- Daniel Eefting, Dr, Principal investigator, Medisch Centrum Westeinde Den HaagErik Vermeulen, Dr, Principal investigator, Spaarne Gasthuis, Haarlem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02487290
- Sponsor's protocol ID
- TripleMed 001
- Acronym
- ACP-T5
- Status last verified
- Feb 2021
- First submitted
- 29 Jun 2015
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no plan to share with other investigators then those participating in the study.
Publications
Smorenburg SPM, Lely RJ, Kelckhoven BV, Vermeulen EG, Yeung KK, Kruse RR, Kraai M, Stassen CM, Jacobs MJ, Hoksbergen AWJ. Initial Clinical Experience With AneuFix Injectable Biocompatible Elastomer for Translumbar Embolization of Type 2 Endoleaks. J Endovasc Ther. 2025 Feb;32(1):57-67. doi: 10.1177/15266028231165731. Epub 2023 Apr 19.
PubMed 37073926
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Treatment Type II Endoleaks With ACP-T5: a Novel Approach.
- ClinicalTrials.gov ID
- NCT02487290
- Acronym / sponsor ID
- ACP-T5 / TripleMed 001
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- AAA, Endoleak
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- TripleMed B.V.Industry (pharma, biotech, devices)
- Collaborators
- Fakkel bvba
- Study start
- 26 Feb 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 1 Jul 2015 (estimated)
- 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 a non-randomized, multi-center safety and feasibility trial of Aneufix ACP-T5 to treat patients with Isolated type II endoleak in the presence of a non-shrinking AAA sac following an EVAR procedure.
Detailed description
The investigational device is called Aneufix, more specifically the model ACP-T5, 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'.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a feasibility study, where initially 5 patients are to be treated.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Aneufix ACP-T5Aneufix ACP-T5 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Persistent type IIa or IIb endoleak (more than 6 months post-EVAR or post-embolization procedure); AND
- Volume of the 'endoleak void' can be determined upfront; AND
- An EVAR without circulatory complications; AND
- An endoleak confirmed by CT scan in preceding 6 weeks demonstrating the high likelihood of the isolated nature of the endoleak; AND
- An aneurysm sac growing in contours after EVAR (per European Guidelines) as documented in the preceding 6 weeks by means of echo (or alternative visualization technique); AND
Key exclusion criteria (10 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 hemostatic disorder 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 |
|---|---|---|
| Aneufix ACP-T5Also: ANEUFIXThe ACP-T5 is injected via translumbar approach into the aneurysm sac near the entrance/exit of bloodvessel. ACP-T5 will cure and block the endoleak. | Device | Treatment |
Primary outcome
Technical success of Type II endoleak repair with Aneufix ACP-T5 as demonstrated by the absence of an endoleak at the end of the procedure.
Time frame: 24h
At the end of the injection procedure, the technical success will be determined by angiographic recording and physician assessment of absence of endoleak. CT scan at 24 hrs is obtained to reconfirm the absence of endoleak.
6 secondary outcomes
Clinical succes rate.
Time frame: 6 and 12 months
Safety aspects I : intra-operative complication rate.
Time frame: All complications observed during the ACP-T5 injection procedure are documented.
Safety aspects II: Peri-operative complication rate.
Time frame: 1 month
Safety aspects III : Mid- and long-term complication rate.
Time frame: 1-12 months
Aneurysm sac rupture.
Time frame: 12 months
Survival.
Time frame: 24 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Derived from this study: PubMed 37073926Smorenburg SPM, Lely RJ, Kelckhoven BV, Vermeulen EG, Yeung KK, Kruse RR, Kraai M, Stassen CM, Jacobs MJ, Hoksbergen AWJ. Initial Clinical Experience With AneuFix Injectable Biocompatible Elastomer for Translumbar Embolization of Type 2 Endoleaks. J Endovasc Ther. 2025 Feb;32(1):57-67. doi: 10.1177/15266028231165731. Epub 2023 Apr 19.
- Individual participant dataSharing planned: No. There is currently no plan to share with other investigators then those participating in the study.
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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.
Daniel Eefting, Dr principal investigator
Medisch Centrum Westeinde Den Haag
Erik Vermeulen, Dr principal investigator
Spaarne Gasthuis, Haarlem
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aneufix ACP-T5 in people with Abdominal Aortic Aneurysm, run by TripleMed B.V. at 2 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 9 inclusion and 10 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: finished, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 of Type II endoleak repair with Aneufix ACP-T5 as demonstrated by the absence of an endoleak at the end of the procedure. (time frame: 24h). 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 NCT02487290, which also lists 1 linked publication.
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 21 Feb 2021.