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ANEUFIX for Endoleaks Type II

NCT02487290 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2021-02-21

No results posted yet for this study

Summary

The study is a non-randomized, multi-center safety and feasibility trial of Aneufix ACP-T5 to treat patients with Isolated type II endoleak in the presence of a non-shrinking AAA sac following an EVAR procedure.

Conditions

  • Abdominal Aortic Aneurysm

Interventions

DEVICE

Aneufix ACP-T5

The ACP-T5 is injected via translumbar approach into the aneurysm sac near the entrance/exit of bloodvessel. ACP-T5 will cure and block the endoleak.

Sponsors & Collaborators

  • Fakkel bvba

    collaborator INDUSTRY

  • TripleMed B.V.

    lead INDUSTRY

Principal Investigators

  • Daniel Eefting, Dr · Medisch Centrum Westeinde Den Haag

  • Erik Vermeulen, Dr · Spaarne Gasthuis, Haarlem

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-26
Primary Completion
2019-02-01
Completion
2020-12-15

Countries

  • 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 NCT02487290 on ClinicalTrials.gov