Feasibility assessment of the prophylactic Use of AneuFix at the time of EVAR implantatio

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 5

Inclusion Criteria

1. Asymptomatic, infrarenal AAA that requires surgery with a high- risk profile
of developing endoleak type II
2. Infrarenal neck according to the IFU of the EVAR device
3. Other aortic-iliac anatomical configuration suitable for EVAR according to
the criteria of the EVAR device to be used
4. Patient having a life expectation of at least 2 years
5. Being older than 18 years
6. Willing and able to comply with the requirements of this clinical study

Exclusion Criteria

1. Patient not able or willing to give written Informed Consent
2. Patient undergoing emergency procedures
3. Patient undergoing EVAR for ruptured or symptomatic AAA,
4. Patient with a suprarenal AAA
5. Patient with an inflammatory AAA (more than minimal wall thickening)
6. 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
7. Patient in which a bilateral retroperitoneal incision is required for EVAR
8. Patient in which a sacrifice of both hypogastric arteries is required
9. Patient with anatomical variations
10. Patient in which the administration of contrast agent is not possible:
proved, severe systemic reaction to contrast agent
11. Patient with active infection present
12. Patients scheduled for or having received an organ transplant
13. Patient with limited life expectation due to other illness (<1 year)
14. Patient with non-iatrogenic bleeding diathesis
15. Patient with connective tissue disease
16. Women of child-bearing potential
17. Patients with evidence at completion angiogram during EVAR of a type Ia or
type III endoleak persistent after balloon inflation.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Technical feasibility of Prophylactic Sac Filling using AneuFix<br /><br>- Absence of aneurysm sac growth at 6 and 12 months (Clinical success)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Intraoperative occurrence of complications<br /><br>- Rate of peri-operative complications (<30 days)<br /><br>- Occurrence of (any type) endoleak<br /><br>- Occurrence of adverse events and adverse device effects at 1, 6 and 12 months<br /><br>- Rate of secondary endovascular or surgical re-interventions at 1, 6 and 12<br /><br>months<br /><br>- Rate of aneurysm rupture at 6 and 12 months<br /><br>- Survival throughout the study up until 24 months</p><br>