search
Back to results

Study of the Enterprise Self-Expanding Stent System With Endovascular Coil Embolization of Wide- Neck Saccular Intracranial Artery Aneurysms

Primary Purpose

Intracranial, Wide-Neck, Saccular Aneurysms

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Cordis Neurovascular Self-Expanding Stent
Sponsored by
Codman & Shurtleff
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracranial, Wide-Neck, Saccular Aneurysms focused on measuring Intracranial, Wide-neck, Saccular, Aneurysms

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: pts with intracranial, wide-neck, saccular aneurysms Exclusion Criteria: Subject with Hunt and Hess Grade IV or V subarachnoid hemorrhage.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 5, 2005
    Last Updated
    January 5, 2009
    Sponsor
    Codman & Shurtleff
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00233753
    Brief Title
    Study of the Enterprise Self-Expanding Stent System With Endovascular Coil Embolization of Wide- Neck Saccular Intracranial Artery Aneurysms
    Official Title
    Cordis Neurovascular Feasibility Study of the Enterprise Self-Expanding Stent System to Facilitate Endovascular Coil Embolization of Wide- Neck Saccular Intracranial Artery Aneurysms
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    December 2005 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Codman & Shurtleff

    4. Oversight

    5. Study Description

    Brief Summary
    Cordis Self Expanding Stent for use with embolic coils for the treatment of wide-neck, intracranial, saccular aneurysms arising from a parent vessel

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Intracranial, Wide-Neck, Saccular Aneurysms
    Keywords
    Intracranial, Wide-neck, Saccular, Aneurysms

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Allocation
    Non-Randomized
    Enrollment
    30 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    Cordis Neurovascular Self-Expanding Stent

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: pts with intracranial, wide-neck, saccular aneurysms Exclusion Criteria: Subject with Hunt and Hess Grade IV or V subarachnoid hemorrhage.

    12. IPD Sharing Statement

    Learn more about this trial

    Study of the Enterprise Self-Expanding Stent System With Endovascular Coil Embolization of Wide- Neck Saccular Intracranial Artery Aneurysms

    We'll reach out to this number within 24 hrs