Trenza Embolization Device for Intrasaccular Aneurysm Treatment

Sponsor
Stryker Neurovascular (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04380350
Collaborator
(none)
106
1
44.5
2.4

Study Details

Study Description

Brief Summary

The purpose of this Post-Market Clinical Follow-up study is to assess the safety and performance of the Trenza in the treatment of intracranial aneurysms.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Prospective, multi-center, single-arm, post-market follow-up study conducted in Europe for the treatment of patients with saccular intracranial aneurysms.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    106 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Trenza Embolization Device for Intrasaccular Aneurysm Treatment
    Actual Study Start Date :
    Dec 17, 2020
    Anticipated Primary Completion Date :
    Mar 1, 2024
    Anticipated Study Completion Date :
    Sep 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Safety primary outcome measure [1 year (± 6 months)]

      Stroke-related neurologic death, or major ipsilateral or disabling stroke in the territory supplied by the treated artery, occurring within 12 months post-procedure

    2. Effectiveness primary outcome measure [1 year (± 6 months)]

      Adequate aneurysm occlusion without retreatment or significant parent artery stenosis (>50% stenosis) using Raymond Roy classification

    Secondary Outcome Measures

    1. Safety secondary outcome measure [1 year (± 6 months)]

      Any stroke event occurring through 12 months post-procedure

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Has a single, target intracranial aneurysm that is suitable for endovascular treatment.
    Exclusion Criteria:
    • Target aneurysm has been previously treated

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hopital Purpan Toulouse France

    Sponsors and Collaborators

    • Stryker Neurovascular

    Investigators

    • Principal Investigator: Christophe Cognard, Pr, Hospital Purpan, Toulouse, France

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Stryker Neurovascular
    ClinicalTrials.gov Identifier:
    NCT04380350
    Other Study ID Numbers:
    • TREAT
    First Posted:
    May 8, 2020
    Last Update Posted:
    Feb 11, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 11, 2022