Tämä sivu käännettiin automaattisesti, eikä käännösten tarkkuutta voida taata. Katso englanninkielinen versio lähdetekstiä varten.

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

tiistai 3. marraskuuta 2026 päivittänyt: 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.

Tutkimuksen yleiskatsaus

Tila

Ei vielä rekrytointia

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

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.

Opintotyyppi

Interventio

Ilmoittautuminen (Arvioitu)

150

Vaihe

  • Ei sovellettavissa

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskeluyhteys

Opiskelupaikat

  • Alankomaat
    • North Holland
      • Amsterdam, North Holland, Alankomaat, 105 AZ

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

22 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

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.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Ennaltaehkäisy
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: 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.
Laite: 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.

Menettely: Endovascular AneuRysm Repair (EVAR)

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

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

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

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Composite Treatment Success at 12 Months
Aikaikkuna: 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
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Incidence of Type II Endoleak (T2EL)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

TripleMed B.V.

Yhteistyökumppanit

Clinfidence B.V.
Xper Research

Tutkijat

  • Opintojohtaja: Hans Brom, Dr., TripleMed B.V.

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Hyödyllisiä linkkejä

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Arvioitu)

Perjantai 15. tammikuuta 2027

Ensisijainen valmistuminen (Arvioitu)

Maanantai 31. joulukuuta 2029

Opintojen valmistuminen (Arvioitu)

Lauantai 3. joulukuuta 2033

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Maanantai 19. lokakuuta 2026

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Tiistai 3. marraskuuta 2026

Ensimmäinen Lähetetty (Todellinen)

Tiistai 10. marraskuuta 2026

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Tiistai 10. marraskuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Tiistai 3. marraskuuta 2026

Viimeksi vahvistettu

Sunnuntai 1. marraskuuta 2026

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • TripleMed 004

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

EI

IPD-suunnitelman kuvaus

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.

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Ei

Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

Ei

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

Tilaa