Overview
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.
Description
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.
Eligibility
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
- Open IMA AND
- 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