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

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Not applicable

Age range

22 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

150 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

TripleMed B.V.

Study start

Jan 15, 2027 Estimated

Primary completion

Dec 31, 2029 Estimated

Study completion

Dec 3, 2033 Estimated

First posted

Nov 10, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts