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RECRUITING

NCT04307992

AneuFix - Prophylactic Sac Filling

Sponsor: TripleMed B.V.

View on ClinicalTrials.gov

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.

Official title: Feasibility Assessment of the Prophylactic Use of AneuFix at the Time of EVAR Implantation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2022-02-15

Completion Date

2025-12-31

Last Updated

2024-06-07

Healthy Volunteers

Conditions

Abdominal Aortic Aneurysm Endoleak

Interventions

DEVICE

Prophylactic 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.

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 * 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

Locations (1)

VUmc

Amsterdam, North Holland, Netherlands