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

Trial details

Who runs it

TripleMed B.V.

Trial code

NCT07928505

Record updated

10 November 2026

Original description

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.Read full original descriptionShow less

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.

Inclusion: 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: Vascular disease and/or anatomy that preclude the safe access and positioning of a catheter to deliver the investigational product into the AAA sac; Cerebrovascular accident within 3 months prior to the procedure; Myocardial infarction and/or major heart surgery within 3 months prior to the procedure; 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; Ruptured, leaking, inflammatory or mycotic (infected) aneurysm; Connective tissue disorder (e.g., Marfan's syndrome); Aneurysmal disease of the descending thoracic aorta; 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; Known hypersensitivity or other contraindication to tantalum; 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; Serum creatinine level > 2.5 mg/dL; Active infection at the time of the index procedure documented by pain, fever, drainage, positive culture, or leukocytosis (WBC>11,000/mm3); Life expectancy of <2 years post-procedure; 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; Aorto-Iliac aneurysms; Aneurysm sac requiring more than 100ml of AneuFix Injectable Polymer to fill; 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; Atrial fibrillation that is not well rate controlled.

ClinicalTrials.gov NCT07928505