RecruitingNot ApplicableNCT04307992

AneuFix - Prophylactic Sac Filling

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

Sponsor

TripleMed B.V.

Enrollment

5 participants

Start Date

Feb 15, 2022

Study Type

INTERVENTIONAL

Conditions

Abdominal Aortic Aneurysm Endoleak

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria12

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
patent lumbar AND a cross-sectional area at the location of the IMA (CSAIMA) >17,5cm2 OR
patent lumbars AND a CSAIMA >15cm2 OR
patent lumbars AND a CSAIMA >12,5 cm2 OR
patent lumbars AND a CSAIMA >10 cm2 OR
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 Criteria17

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

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Interventions

DEVICEProphylactic sac filling with AneuFix

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.