search
Back to results

GORE EXCLUDER® Endoprosthesis - Low Permeability in Treatment of Abdominal Aortic Aneurysms

Primary Purpose

Aortic Aneurysm, Abdominal

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
GORE EXCLUDER® Bifurcated Endoprosthesis-Low Permeability
Sponsored by
W.L.Gore & Associates
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Aneurysm, Abdominal

Eligibility Criteria

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

Inclusion Criteria:

  1. Infrarenal Abdominal Aortic Aneurysms less than 4.5 cm in diameter
  2. Anatomy meets EXCLUDER Bifurcated Endoprosthesis - Low Permeability specification criteria per Instructions for Use
  3. Access vessel able to receive 18 French introducer sheath
  4. Life expectancy > 2 years
  5. Appropriate candidate for endovascular repair
  6. Ability to comply with protocol requirements including follow-up
  7. 21 years of age or older, male or infertile female**

Exclusion Criteria:

  1. Mycotic or ruptured aneurysm
  2. Participating in another investigational device or drug study within one year
  3. Documented history of drug abuse within six months
  4. Myocardial infarction or cerebral vascular accident within six weeks
  5. Pulmonary insufficiency requiring chronic home oxygen or inability to ambulate due to pulmonary function
  6. Iliac anatomy that would require occlusion of both internal iliac arteries
  7. Planned occlusion or reimplantation of significant mesenteric or renal arteries
  8. Planned concomitant surgical procedure or previous major surgery within 30 days
  9. Previous prosthesis placement in the aorta or iliac arteries
  10. Degenerative connective tissue disease (e.g., Marfan's and Ehlers Danlos Syndrome)

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Number of Subjects With Aneurysm Volume Increase Greater Than 10% at 2 Years Post-procedure

    Secondary Outcome Measures

    Number of Subjects With Device Efficacy Events

    Full Information

    First Posted
    December 20, 2007
    Last Updated
    December 8, 2017
    Sponsor
    W.L.Gore & Associates
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00593814
    Brief Title
    GORE EXCLUDER® Endoprosthesis - Low Permeability in Treatment of Abdominal Aortic Aneurysms
    Official Title
    A Clinical Evaluation of the GORE EXCLUDER® Bifurcated Endoprosthesis - Low Permeability in the Primary Treatment of Infrarenal Abdominal Aortic Aneurysms
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2005 (undefined)
    Primary Completion Date
    February 2009 (Actual)
    Study Completion Date
    February 2009 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    W.L.Gore & Associates

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the performance of the GORE EXCLUDER® Bifurcated Endoprosthesis-Low Permeability in the primary treatment of infrarenal abdominal aortic aneurysms.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Aortic Aneurysm, Abdominal

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    139 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    GORE EXCLUDER® Bifurcated Endoprosthesis-Low Permeability
    Intervention Description
    Implant
    Primary Outcome Measure Information:
    Title
    Number of Subjects With Aneurysm Volume Increase Greater Than 10% at 2 Years Post-procedure
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    Number of Subjects With Device Efficacy Events
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Infrarenal Abdominal Aortic Aneurysms less than 4.5 cm in diameter Anatomy meets EXCLUDER Bifurcated Endoprosthesis - Low Permeability specification criteria per Instructions for Use Access vessel able to receive 18 French introducer sheath Life expectancy > 2 years Appropriate candidate for endovascular repair Ability to comply with protocol requirements including follow-up 21 years of age or older, male or infertile female** Exclusion Criteria: Mycotic or ruptured aneurysm Participating in another investigational device or drug study within one year Documented history of drug abuse within six months Myocardial infarction or cerebral vascular accident within six weeks Pulmonary insufficiency requiring chronic home oxygen or inability to ambulate due to pulmonary function Iliac anatomy that would require occlusion of both internal iliac arteries Planned occlusion or reimplantation of significant mesenteric or renal arteries Planned concomitant surgical procedure or previous major surgery within 30 days Previous prosthesis placement in the aorta or iliac arteries Degenerative connective tissue disease (e.g., Marfan's and Ehlers Danlos Syndrome)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mark F Fillinger, MD
    Organizational Affiliation
    Dartmouth-Hitchcock Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    GORE EXCLUDER® Endoprosthesis - Low Permeability in Treatment of Abdominal Aortic Aneurysms

    We'll reach out to this number within 24 hrs