NCT04307992

AneuFix - Prophylactic Sac Filling

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (estimated)
• Sponsor: TripleMed B.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 of existing draining arteries. ANEUFIX is a polymer that cures rapidly (2-4 min at 37°C) after injection into the AAA-sac close to the nidus.

Conditions

• Abdominal Aortic Aneurysm
• Endoleak

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-02-15
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2020-03-13
• Last updated: 2024-06-07

Locations

1 site across 1 country: Netherlands