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PFLEX: Pipeline™ Flex Embolization Device With Shield Technology™ Clinical Study

Sponsor
Medtronic Neurovascular Clinical Affairs (Industry)
Overall Status
Completed
CT.gov ID
NCT02390037
Collaborator
(none)
50
Enrollment
7
Locations
20.2
Duration (Months)
7.1
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of the study is to assess the incidence of safety outcomes in patients treated with Pipeline™ Flex embolization device with Shield Technology™.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Pipeline™ Flex Embolization Device With Shield Technology™ Clinical Study
    Study Start Date :
    Mar 1, 2015
    Actual Primary Completion Date :
    Nov 4, 2016
    Actual Study Completion Date :
    Nov 4, 2016

    Outcome Measures

    Primary Outcome Measures

    1. Occurrence of major stroke or neurological death [1 year]

    Secondary Outcome Measures

    1. Device related neurologic adverse event rate [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Subject has provided written informed consent using the IRB/EC-approved consent form and agrees to comply with protocol requirements.

    2. Age 18-80 years.

    3. Subject has already been selected for flow diversion therapy as the appropriate treatment.

    4. Subject has an unruptured target intracranial aneurysm (IA).

    5. Subject has a target IA located in the anterior or posterior circulation.

    Exclusion Criteria:

    1. Major surgery in the past 30 days.

    2. Any known contraindication to treatment with the Pipeline™ Flex embolization device with Shield Technology™ per Instructions for Use.

    3. Pregnant or breast-feeding women or women who wish to become pregnant during the length of study participation.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ziekenhuis Oost-Limburg Genk Belgium
    2 Alfried Krupp Krankenhaus Essen Germany
    3 Uniklinik Koln Koln Germany
    4 Hellenic Air Force Hospital Athens Greece
    5 IRCCS Fondazione Istituto Neurologico C Besta Milan Italy
    6 Hospital Clinico Universitario de Valladolid Valladolid Spain
    7 Queen Elizabeth Hospital Birmingham Birmingham United Kingdom

    Sponsors and Collaborators

    • Medtronic Neurovascular Clinical Affairs

    Investigators

    • Principal Investigator: Edoardo Boccardi, M.D., Ospedale Niguarda "Ca' Granda"

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Medtronic Neurovascular Clinical Affairs
    ClinicalTrials.gov Identifier:
    NCT02390037
    Other Study ID Numbers:
    • NV PED 09
    First Posted:
    Mar 17, 2015
    Last Update Posted:
    Feb 1, 2019
    Last Verified:
    Jan 1, 2019
    Additional relevant MeSH terms:
    Aneurysm

    Study Results

    No Results Posted as of Feb 1, 2019