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ANEUFIX for Endoleak Type II Repair

NCT03918460 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-04-10

No results posted yet for this study

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.

Conditions

  • Abdominal Aortic Aneurysm
  • Endoleak

Interventions

DEVICE

ANEUFIX

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

Sponsors & Collaborators

  • Trium Clinical Consulting

    collaborator INDUSTRY

  • TripleMed B.V.

    lead INDUSTRY

Principal Investigators

  • Arjan WJ Hoksbergen, Dr · VUmc Heelkunde, Amsterdam

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-13
Primary Completion
2025-08-31
Completion
2026-02-28

Countries

  • Belgium
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03918460 on ClinicalTrials.gov