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

3 novembre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

150

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Pays-Bas
    • North Holland
      • Amsterdam, North Holland, Pays-Bas, 105 AZ

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

22 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Dispositif: 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.

Procédure: Endovascular AneuRysm Repair (EVAR)

Endovascular placement of a commercially available stent graft to exclude the abdominal aortic aneurysm from systemic blood flow.
Comparateur actif: Standard EVAR

Participants will undergo standard EVAR according to the site's standard practice without adjunctive treatment with AneuFix Injectable Polymer.
Procédure: Endovascular AneuRysm Repair (EVAR)

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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Composite Treatment Success at 12 Months
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Incidence of Type II Endoleak (T2EL)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

TripleMed B.V.

Collaborateurs

Clinfidence B.V.
Xper Research

Les enquêteurs

  • Directeur d'études: Hans Brom, Dr., TripleMed B.V.

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

15 janvier 2027

Achèvement primaire (Estimé)

31 décembre 2029

Achèvement de l'étude (Estimé)

3 décembre 2033

Dates d'inscription aux études

Première soumission

19 octobre 2026

Première soumission répondant aux critères de contrôle qualité

3 novembre 2026

Première publication (Réel)

10 novembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

10 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • TripleMed 004

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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