NCT03918460

ANEUFIX for Endoleak Type II Repair

Treatment of Type II Endoleak With ANEUFIX: Assessment of Safety, Performance and Clinical Benefit.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: TripleMed B.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is non-randomized, multicenter international safety, performance and clinical benefit outcome assessment of ANEUFIX to treat patients with isolated type II endoleak in the presence of a growing AAA-sac following an EVAR procedure more than 6 months ago.

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	ANEUFIX	ANEUFIX is administered through translumbar injection into the AAA using imaging techniques to guide the place of injection.

Timeline

• Start date: 2020-05-13
• Primary completion: 2025-08-31
• Completion: 2026-02-01
• First posted: 2019-04-17
• Last updated: 2024-04-10

Locations

9 sites across 2 countries: Belgium, Netherlands