Clincosm LogoSign in Get a demo

PAA 12-01: Evaluation of GORE® VIABAHN® Endoprosthesis for Popliteal Artery Aneurysm

Sponsor
W.L.Gore & Associates (Industry)
Overall Status
Terminated
CT.gov ID
NCT01902888
Collaborator
(none)
3
Enrollment
3
Locations
9
Duration (Months)
1
Patient Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a multicenter, non-randomized, single arm, retrospective study of GORE® VIABAHN® Endoprosthesis for the treatment of a Popliteal Artery Aneurysm (PAA).

Condition or Disease Intervention/Treatment Phase
  • Device: GORE® VIABAHN® Endoprosthesis

Detailed Description

The primary objective is to evaluate the safety and efficacy of the GORE® VIABAHN® Endoprosthesis for the treatment of subjects with Popliteal Artery Aneurysms. The study population includes subjects with an asymptomatic aneurysm (≥ 2 cm diameter) of the popliteal artery, symptomatic aneurysm (no diameter requirement) of the popliteal artery, or presence of mural thrombus (no diameter requirement) of the popliteal artery treated with the GORE® VIABAHN® Endoprosthesis between January 1, 2002 and December 31, 2010. Starting with most recently treated within the above date range, patients meeting Inclusion/Exclusion will be enrolled, until a minimum of 50 subjects with adequate follow up to determine primary endpoints through 12 months will be provided.

Study Design

Study Type:
Observational
Actual Enrollment :
3 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Retrospective Evaluation of the GORE® VIABAHN® Endoprosthesis for a Popliteal Artery Aneurysm Indication
Study Start Date :
Jul 1, 2013
Actual Primary Completion Date :
Apr 1, 2014
Actual Study Completion Date :
Apr 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Popliteal aneurysm

GORE® VIABAHN® Endoprosthesis used to treat popliteal aneurysm

Device: GORE® VIABAHN® Endoprosthesis
Other Names:
  • Viabahn

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Primary Efficacy Endpoint: The Number of Patients That do Not Have a Failure of Technical Success or Loss of Primary Patency. [12 months following initial study procedure]

      A composite of freedom from failure of technical success or loss of primary patency at 12 months

    2. Primary Safety Endpoint: Number of Serious Adverse Events (Related to Initial Procedure or the Device Itself) That Occur Within 30 Days of the Initial Study Procedure. [30 days following initial study procedure]

      30 day serious adverse events related to the initial study procedure or the study device.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Received a GORE® VIABAHN® Endoprosthesis between January 1, 2002 and December 31, 2010 to treat a popliteal artery aneurysm;

    • Had an asymptomatic aneurysm (≥ 2 cm diameter) of the popliteal artery, or symptomatic aneurysm (no diameter requirement) of the popliteal artery, or the presence of mural thrombus (no diameter requirement) of the popliteal artery;

    • Was 18 years of age or older; and

    • Had an elective popliteal artery aneurysm procedure.

    Exclusion Criteria:

    • Bilateral popliteal artery aneurysms with initial treatment on the same day

    • Had previous surgery for the popliteal artery aneurysm in the study limb

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Baptist Health Miami Florida United States
    2 The Vascular Group of Naples Naples Florida United States
    3 Washington University School of Medicine Saint Louis Missouri United States

    Sponsors and Collaborators

    • W.L.Gore & Associates

    Investigators

    • Study Director: Hector Novoa, BS, W. L. Gore & Associates, Inc (sponsor)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    W.L.Gore & Associates
    ClinicalTrials.gov Identifier:
    NCT01902888
    Other Study ID Numbers:
    • PAA 12-01
    First Posted:
    Jul 18, 2013
    Last Update Posted:
    Jun 19, 2015
    Last Verified:
    Jun 1, 2015
    Keywords provided by W.L.Gore & Associates
    popliteal artery
    aneurysm
    popliteal artery aneurysm
    asymptomatic aneurysm
    mural thrombus
    Viabahn
    Gore
    Endoprosthesis
    Additional relevant MeSH terms:
    Aneurysm

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Popliteal Aneurysm
    Arm/Group Description GORE® VIABAHN® Endoprosthesis used to treat popliteal aneurysm GORE® VIABAHN® Endoprosthesis
    Period Title: Overall Study
    STARTED 3
    COMPLETED 0
    NOT COMPLETED 3

    Baseline Characteristics

    Arm/Group Title Popliteal Aneurysm
    Arm/Group Description GORE® VIABAHN® Endoprosthesis used to treat popliteal aneurysm GORE® VIABAHN® Endoprosthesis
    Overall Participants 3
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    65
    (12.28)
    Sex: Female, Male (Count of Participants)
    Female
    0
    0%
    Male
    3
    100%
    Region of Enrollment (participants) [Number]
    United States
    3
    100%

    Outcome Measures

    1. Primary Outcome
    Title Primary Efficacy Endpoint: The Number of Patients That do Not Have a Failure of Technical Success or Loss of Primary Patency.
    Description A composite of freedom from failure of technical success or loss of primary patency at 12 months
    Time Frame 12 months following initial study procedure

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Popliteal Aneurysm
    Arm/Group Description GORE® VIABAHN® Endoprosthesis used to treat popliteal aneurysm GORE® VIABAHN® Endoprosthesis
    Measure Participants 0
    2. Primary Outcome
    Title Primary Safety Endpoint: Number of Serious Adverse Events (Related to Initial Procedure or the Device Itself) That Occur Within 30 Days of the Initial Study Procedure.
    Description 30 day serious adverse events related to the initial study procedure or the study device.
    Time Frame 30 days following initial study procedure

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Popliteal Aneurysm
    Arm/Group Description GORE® VIABAHN® Endoprosthesis used to treat popliteal aneurysm GORE® VIABAHN® Endoprosthesis
    Measure Participants 0

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Popliteal Aneurysm
    Arm/Group Description GORE® VIABAHN® Endoprosthesis used to treat popliteal aneurysm GORE® VIABAHN® Endoprosthesis
    All Cause Mortality
    Popliteal Aneurysm
    Affected / at Risk (%) # Events
    Total / (NaN)
    Serious Adverse Events
    Popliteal Aneurysm
    Affected / at Risk (%) # Events
    Total 0/0 (NaN)
    Other (Not Including Serious) Adverse Events
    Popliteal Aneurysm
    Affected / at Risk (%) # Events
    Total 0/0 (NaN)

    Limitations/Caveats

    Early termination of study. No subject analysis done

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Arthur Scott / Clinical Study Manager
    Organization W.L. Gore and Associates, Inc.
    Phone 623.208.3365
    Email artscott@wlgore.com
    Responsible Party:
    W.L.Gore & Associates
    ClinicalTrials.gov Identifier:
    NCT01902888
    Other Study ID Numbers:
    • PAA 12-01
    First Posted:
    Jul 18, 2013
    Last Update Posted:
    Jun 19, 2015
    Last Verified:
    Jun 1, 2015