Status:
RECRUITING
AneuFix - Prophylactic Sac Filling
Lead Sponsor:
TripleMed B.V.
Conditions:
Abdominal Aortic Aneurysm
Endoleak
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04307992
Start Date
February 15 2022
End Date
December 31 2025
Last Update
June 7 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
VUmc
Amsterdam, North Holland, Netherlands, 1081 HV