An interventional study of AneuFix Injectable Polymer and Endovascular AneuRysm Repair (EVAR) in Endoleak After Endovascular Aneurysm Repair and Aortic Aneurysm Abdominal, sponsored by TripleMed B.V.. Not yet recruiting at 1 site in Netherlands. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by TripleMed B.V. · Not applicable, Interventional, and Prevention
The goal of this clinical trial is to evaluate the safety and effectiveness of adding AneuFix Injectable Polymer sac filling to standard endovascular aneurysm repair (EVAR) in patients with an infrarenal abdominal aortic aneurysm (AAA) who are at high risk of developing a Type II endoleak after EVAR. The study will include adult men and women who are candidates for elective EVAR and meet predefined imaging criteria indicating a high risk of post-procedural Type II endoleak.
The main questions it aims to answer are:
Researchers will compare EVAR plus AneuFix Injectable Polymer sac filling with standard EVAR alone to determine whether sac filling improves aneurysm-related outcomes and reduces complications associated with persistent blood flow into the aneurysm sac following EVAR.
Participants will:
This multicenter, randomized, controlled study plans to enroll approximately 150 participants at sites across Europe and follow them for up to 5 years after treatment.
Abdominal aortic aneurysm (AAA) is a progressive disease that can lead to aneurysm rupture if left untreated. Endovascular aneurysm repair (EVAR) has become a widely used treatment option for infrarenal AAA because it is less invasive than open surgical repair. However, long-term durability of EVAR can be affected by complications, particularly endoleaks that allow persistent blood flow within the aneurysm sac. Persistent sac pressurization may result in continued aneurysm sac enlargement, the need for secondary interventions, and, in some cases, aneurysm rupture. These complications contribute substantially to the long-term follow-up burden and healthcare costs associated with EVAR.
Type II endoleaks are among the most common endoleak types observed following EVAR and occur when retrograde blood flow enters the aneurysm sac through aortic side branches, such as the inferior mesenteric artery or lumbar arteries. Patients with specific anatomical characteristics are known to be at increased risk for development of Type II endoleaks and subsequent aneurysm sac enlargement.
AneuFix Injectable Polymer is an investigational injectable polymer designed to fill the aneurysm sac at the time of EVAR and interrupt blood flow through aortic side branches communicating with the sac. The polymer is delivered into the aneurysm sac after endograft placement, where it cures in situ to form a durable implant. The approach is intended to provide more complete occlusion of the aneurysm sac environment and associated side-branch ostia compared with selective embolization techniques.
Previous clinical experience with the AneuFix technology, including pilot, feasibility, and Type II endoleak treatment studies, has demonstrated procedural feasibility and provided preliminary evidence supporting further evaluation in a randomized controlled study.
The SEAL-EVAR study is a prospective, multicenter, randomized controlled trial designed to evaluate whether adjunctive aneurysm sac filling with AneuFix Injectable Polymer, when used in combination with standard EVAR, improves clinical outcomes compared with standard EVAR alone in patients at increased risk of developing Type II endoleaks. The study will assess both safety and effectiveness outcomes, including freedom from Type II endoleak, prevention of aneurysm sac enlargement, and reduction in AAA-related reinterventions. Long-term follow-up will be performed to evaluate durability of treatment effects and continued safety.
The results of this study are intended to provide high-quality clinical evidence regarding the role of prophylactic aneurysm sac filling as an adjunct to EVAR and to support future clinical, regulatory, and health-economic evaluations of this treatment strategy.
467 studies on the registry are indexed under Aortic Aneurysm, Abdominal; 99 are open to participants now.
This study's planned enrollment of 150 is above the median of 66 across 228 interventional studies indexed under Aortic Aneurysm, Abdominal.
Browse Aortic Aneurysm, Abdominal studies →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.
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.
High risk of developing T2EL after the EVAR procedure, based on one or more of the following criteria observed on a preoperative CTA scan. High risk participants are those with:
Exclusion Criteria:
General
Anatomical
Procedural
Medical History/Conditions
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.
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will undergo standard EVAR followed by delivery of AneuFix Injectable Polymer into the aneurysm sac according to the study procedure. The polymer is intended to fill the aneurysm sac and occlude blood flow pathways that may contribute to the development of Type II endoleaks.
Device: AneuFix Injectable Polymer · Procedure: Endovascular AneuRysm Repair (EVAR)
Participants will undergo standard EVAR according to the site's standard practice without adjunctive treatment with AneuFix Injectable Polymer.
Procedure: Endovascular AneuRysm Repair (EVAR)
Injectable polymer intended for delivery into the abdominal aortic aneurysm sac during EVAR to provide aneurysm sac filling and occlusion of blood flow pathways associated with Type II endoleak formation.
Endovascular placement of a commercially available stent graft to exclude the abdominal aortic aneurysm from systemic blood flow.
Composite Treatment Success at 12 Months
Proportion of subjects achieving treatment success at 12 months, defined as single composite of: * Freedom from incidence of Type II endoleak; * Freedom from Sac Growth (\>5 mm); * Freedom from AAA-related secondary intervention.
Time frame: 12 Months
Major Adverse Event (MAE) rate within the 30-day follow-up period after the procedure
Major Adverse Event (MAE) rate within the 30-day follow-up period after the procedure. * MAE related to the AneuFix Injectable Polymer Sac Filling procedure: ischemia in end organs (bowel, spine, legs) or paraplegia due to non-target embolization, perforation, rupture * MAE related to the EVAR procedure: all-cause mortality, AAA-related mortality, myocardial infarction, renal failure, respiratory failure, stroke or procedural blood loss \>1000 ml. * Conversion to Open Repair
Time frame: 30 Days Post-Procedure
Incidence of Type II Endoleak (T2EL)
Percentage of subjects with a persistent or recurrent Type II endoleak confirmed by imaging assessment.
Time frame: 1 month, 6 months, 2 years, 3 years, 4 years, and 5 years Post-Procedure
Incidence of Type I, III or IV Endoleak
Percentage of subjects with a Type I, III or IV endoleak identified on imaging assessment.
Time frame: 1 month, 6 months, 2 years, 3 years, 4 years, and 5 years Post-Procedure
Change in Aneurysm Sac Diameter
Change in maximum aneurysm sac diameter measured in millimeters (mm) compared with baseline.
Time frame: 2 years, 3 years, 4 years, and 5 years Post-Procedure
Change in Aneurysm Sac Volume
Change in aneurysm sac volume measured in cubic centimeters (cm³) compared with baseline.
Time frame: 2 years, 3 years, 4 years, and 5 years Post-Procedure
Aneurysm-Related Reintervention Rate
Percentage of subjects requiring aneurysm-related reintervention. Reinterventions will be categorized as open surgical or endovascular procedures and the reason will be recorded.
Time frame: Until the end of study (5 years)
Plan to share: No — The Clinical Investigation Plan does not include provisions for sharing individual participant data with external researchers. Study results will be reported through the Clinical Investigation Report and scientific publications.
Start is estimated for Jan 2027; primary completion for Dec 2029, 35 months later.
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 35 months is below that.
Counting every sponsor, half of 94 studies reached it within 43 months; a quarter within 23 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
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 ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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