AneuFix - Prophylactic Sac Filling
Key facts
- Where
- Almelo, Amsterdam, and Haarlem, NetherlandsSee the 3 sites
Where in Netherlands
- ZGT AlmeloAlmelo, NetherlandsNo longer taking part
- VUmcAmsterdam, NetherlandsNo longer taking part
- Spaarne Gasthuis HaarlemHaarlem, NetherlandsNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- TripleMed B.V.
- Trial code
- NCT04307992
- Record updated
- 22 October 2026
- Original description
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.Read full original descriptionShow less
Feasibility Assessment of the Prophylactic Use of AneuFix at the Time of EVAR Implantation
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.
Inclusion: Asymptomatic, infrarenal AAA that requires surgery with a high-risk profile of developing endoleak type II in line with the recommendations of Fabre et al:v; a patent IMA, 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; 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: Patients scheduled for or having received an organ transplant; Patient with active infection present; Patient with limited life expectation due to other illness (<1 year); Patient with non-iatrogenic bleeding diathesis; Patient with connective tissue disease; 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; 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.