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Safety and Effectiveness Assessment of AneuFix Injectable Polymer Sac Filling to Assure Long-term Durability of EVAR. (SEAL-EVAR)

3 november 2026 bijgewerkt door: TripleMed B.V.

SEAL-EVAR: Safety and Effectiveness Assessment of AneuFix Injectable Polymer Sac Filling to Assure Long-term Durability of EVAR. A Randomized Controlled Multicenter Trial.

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:

  • Does the addition of AneuFix Injectable Polymer to standard EVAR reduce the occurrence of Type II endoleaks, prevent aneurysm sac growth, and reduce the need for AAA-related reinterventions within 12 months after treatment?
  • Is treatment with AneuFix Injectable Polymer safe, as measured by the rate of major adverse events within 30 days after the procedure?

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:

  • Undergo screening assessments, including review of medical history, imaging studies, and eligibility criteria.
  • Be randomly assigned in a 2:1 ratio to receive either:
  • Standard EVAR with AneuFix Injectable Polymer sac filling, or
  • Standard EVAR alone.
  • Attend follow-up visits at approximately 1 month, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years after treatment.
  • Undergo imaging assessments, including CT angiography and ultrasound or magnetic resonance angiography, to evaluate the presence of endoleaks, aneurysm sac size, and other aneurysm-related outcomes.
  • Be monitored for adverse events, reinterventions, aneurysm-related complications, and survival throughout the 5-year follow-up period.
  • Complete quality-of-life questionnaires at selected study visits.

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

150

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Nederland
    • North Holland
      • Amsterdam, North Holland, Nederland, 105 AZ

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

22 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Age over 22 years

  • Presence of an infrarenal AAA with a maximum diameter of at least 5 cm for women and 5.5 cm for men

  • 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:

    • A patent inferior mesenteric artery 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

  • Subject or legal caregiver's willingness and ability to comply with the requirements of this clinical study and provide written informed consent

Exclusion Criteria:

General

  • Inability to provide informed consent.
  • Enrolled in another clinical study that could interfere with the outcomes being studied in this trial.
  • Unable or unwilling to comply with study follow-up requirements.
  • Prisoner or member of other vulnerable population

Anatomical

  • Vascular disease and/or anatomy that preclude the safe access and positioning of a catheter to deliver the investigational product into the AAA sac.
  • Aorto-Iliac aneurysms
  • Aneurysm sac requiring more than 100ml of AneuFix Injectable Polymer to fill
  • Ruptured, leaking, inflammatory or mycotic (infected) aneurysm.
  • Connective tissue disorder (e.g., Marfan's syndrome)
  • Aneurysmal disease of the descending thoracic aorta
  • Proximal abdominal aneurysm extent including or above the renal arteries
  • Calcification at the aortic bifurcation to common/internal iliac bifurcation, that might lead to access difficulties

Procedural

  • Use of endograft without support struts in the bifurcation (e.g. Endologix - Alto)
  • Use of an aortic stent graft other than those specified for a particular site
  • Planned off-label use of the chosen stent graft
  • Use of fenestrated stent grafts or chimney techniques
  • Use of embolic products to prophylactically or concomitantly embolize the inferior mesenteric artery, lumbar arteries, renal accessory arteries, or internal iliac arteries
  • Inability to land the distal-most portion of the EVAR stent graft limbs, including extensions, above the internal iliac arteries, except when the internal iliac artery pre-procedure is already occluded.

Medical History/Conditions

  • Coagulopathy or uncontrolled bleeding disorder
  • Serum creatinine level > 2.5 mg/dL
  • Cerebrovascular accident within 3 months prior to the procedure
  • Myocardial infarction and/or major heart surgery within 3 months prior to the procedure
  • Atrial fibrillation that is not well rate controlled
  • Life expectancy of <2 years post-procedure
  • Known hypersensitivity or other contraindication to tantalum
  • Active infection at the time of the index procedure documented by pain, fever, drainage, positive culture, or leukocytosis (WBC>11,000/mm3)
  • A condition that inhibits radiographic visualization during the implantation procedure
  • History of allergy to contrast medium that cannot be managed medically, or subject is unable to have a CTA with contrast for any reason.
  • Uncontrolled co-morbid medical condition, including mental health issues, that would adversely affect participation in the trial
  • Pregnant or lactating female: for females of child-bearing potential, based on a positive pregnancy test within 7 days prior to the procedure or refusal to use a medically accepted method of birth control for the duration of the trial.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: EVAR + AneuFix Injectable Polymer

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.
Apparaat: AneuFix Injectable Polymer

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.

Procedure: Endovascular AneuRysm Repair (EVAR)

Endovascular placement of a commercially available stent graft to exclude the abdominal aortic aneurysm from systemic blood flow.
Actieve vergelijker: Standard 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)

Endovascular placement of a commercially available stent graft to exclude the abdominal aortic aneurysm from systemic blood flow.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Composite Treatment Success at 12 Months
Tijdsspanne: 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.
12 Months
Major Adverse Event (MAE) rate within the 30-day follow-up period after the procedure
Tijdsspanne: 30 Days Post-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
30 Days Post-Procedure

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of Type II Endoleak (T2EL)
Tijdsspanne: 1 month, 6 months, 2 years, 3 years, 4 years, and 5 years Post-Procedure

Percentage of subjects with a persistent or recurrent Type II endoleak confirmed by imaging assessment.
1 month, 6 months, 2 years, 3 years, 4 years, and 5 years Post-Procedure
Incidence of Type I, III or IV Endoleak
Tijdsspanne: 1 month, 6 months, 2 years, 3 years, 4 years, and 5 years Post-Procedure

Percentage of subjects with a Type I, III or IV endoleak identified on imaging assessment.
1 month, 6 months, 2 years, 3 years, 4 years, and 5 years Post-Procedure
Change in Aneurysm Sac Diameter
Tijdsspanne: 2 years, 3 years, 4 years, and 5 years Post-Procedure

Change in maximum aneurysm sac diameter measured in millimeters (mm) compared with baseline.
2 years, 3 years, 4 years, and 5 years Post-Procedure
Change in Aneurysm Sac Volume
Tijdsspanne: 2 years, 3 years, 4 years, and 5 years Post-Procedure

Change in aneurysm sac volume measured in cubic centimeters (cm³) compared with baseline.
2 years, 3 years, 4 years, and 5 years Post-Procedure
Aneurysm-Related Reintervention Rate
Tijdsspanne: Until the end of study (5 years)

Percentage of subjects requiring aneurysm-related reintervention. Reinterventions will be categorized as open surgical or endovascular procedures and the reason will be recorded.
Until the end of study (5 years)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

TripleMed B.V.

Medewerkers

Clinfidence B.V.
Xper Research

Onderzoekers

  • Studie directeur: Hans Brom, Dr., TripleMed B.V.

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

15 januari 2027

Primaire voltooiing (Geschat)

31 december 2029

Studie voltooiing (Geschat)

3 december 2033

Studieregistratiedata

Eerst ingediend

19 oktober 2026

Eerst ingediend dat voldeed aan de QC-criteria

3 november 2026

Eerst geplaatst (Werkelijk)

10 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 november 2026

Laatste update ingediend die voldeed aan QC-criteria

3 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • TripleMed 004

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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