AneuFix - Prophylactic Sac Filling

Study Overview
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Brief Summary
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This study is set up to assess the feasibility and safety of the clinical procedure using AneuFix in a prophylactic setting at the time of EVAR endograft implantation.

Detailed Description
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The investigational device is called ANEUFIX, which is a product treating the endoleak by blockage of backflowing blood vessels, i.e. by filling the endoleak void and nidus of feeding artery and exit of existing draining arteries. ANEUFIX is a polymer that cures rapidly (2-4 min at 37°C) after injection into the AAA-sac close to the nidus.

Official Title
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Feasibility Assessment of the Prophylactic Use of AneuFix at the Time of EVAR Implantation

Conditions
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Abdominal Aortic Aneurysm, Endoleak

Intervention / Treatment
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* Device: Prophylactic sac filling with AneuFix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Asymptomatic, infrarenal AAA that requires surgery with a high-risk profile of developing endoleak type II in line with the recommendations of Guntner et al: - Open IMA AND 1 patent lumbar AND a cross-sectional area at the location of the IMA (CSAIMA) >17,5cm2 OR 2 patent lumbars AND a CSAIMA >15cm2 OR 3 patent lumbars AND a CSAIMA >12,5 cm2 OR 4 patent lumbars AND a CSAIMA >10 cm2 OR 5 patent lumbars AND a CSAIMA >7,5 cm2 Infrarenal neck according to the IFU of the EVAR device Other aortic-iliac anatomical configuration suitable for EVAR according to the criteria of the EVAR device to be used Patient having a life expectation of at least 2 years Being older than 18 years Willing and able to comply with the requirements of this clinical study Exclusion Criteria: Patient not able or willing to give written Informed Consent Patient undergoing emergency procedures Patient undergoing EVAR for ruptured or symptomatic AAA, Patient with a suprarenal AAA Patient with an inflammatory AAA (more than minimal wall thickening) Patient with an infrarenal neck unsuitable for endovascular fixation (including so called hostile necks) or aortic-iliac anatomic configuration otherwise unsuitable for EVAR according to criteria of the device to be used Patient in which a bilateral retroperitoneal incision is required for EVAR Patient in which a sacrifice of both hypogastric arteries is required Patient with anatomical variations, i.e. horseshoe-kidney, arteries requiring reimplantation Patient in which the administration of contrast agent is not possible: proved, severe systemic reaction to contrast agent Patient with active infection present Patients scheduled for or having received an organ transplant Patient with limited life expectation due to other illness (<1 year) Patient with non-iatrogenic bleeding diathesis Patient with connective tissue disease Women of child-bearing potential Patients with evidence at completion angiogram during EVAR of a type Ia or type III endoleak persistent after balloon inflation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: The current study is a follow-up study on the previous feasibility study where ACP-T5 was used. After increasing the % tantalum in ANEUFIX to make the product more detectable under X-ray, the current study is a pilot study that (1) evaluates the technical feasibility of the prophylactic use of AneuFix during EVAR implentation and (2) assesses the rate of endoleaks after EVAR in 5 patients.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Device: ANEUFIX | Device: Prophylactic sac filling with AneuFix<br>* ANEUFIX is administered by injection into the AAA via transferal access at the time of EVAR placement using imaging techniques to guide the place of injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Success | Technical Success as demonstrated by the feasibility to fill the AAA sac after EVAR during the same procedure, and by the rate of (all) endoleaks after EVAR followed by the AneuFix procedure | 24 hours | 
| Clinical Success rate | Clinical Success as demonstrated by the occurrence of type II endoleaks at 6 months after EVAR, and aneurysmal sac growth at 6 months after EVAR | 6 months | 
| Clinical Success rate | Clinical Success as demonstrated by the occurrence of type II endoleaks at 12 months after EVAR, and aneurysmal sac growth at 12 months after EVAR | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative occurrence of complications | Adverse events occurring during the surgical intervention are registered. | 24 hours | 
| Peri-operative complications | Rate of peri-operative complications | 30 days | 
| Prevention of (any type of) endoleak | Occurrence of (any type of) endoleak | 1, 6 and 12 months | 
| adverse events | Occurrence of adverse events and adverse device effects | 1, 6 and 12 months | 
| Re-interventions | Rate of secondary endovascular or surgical re-interventions | 1, 6 and 12 months | 
| Aneurysm rupture | Rate of aneurysm rupture | 6 and 12 months | 
| Proportion of patients surviving 24 months after treatment | Survival throughout the study up until 24 months | 24 months |