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

June 17, 2015 updated by: W.L.Gore & Associates

Retrospective Evaluation of the GORE® VIABAHN® Endoprosthesis for a Popliteal Artery Aneurysm Indication

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States
        • Baptist Health
      • Naples, Florida, United States
        • The Vascular Group of Naples
    • Missouri
      • Saint Louis, Missouri, United States
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who had popliteam aneurysm and were treated with GORE® VIABAHN® Endoprosthesis between January 1, 2002 and December 31, 2010.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Popliteal aneurysm
GORE® VIABAHN® Endoprosthesis used to treat popliteal aneurysm
Device: GORE® VIABAHN® Endoprosthesis
Other Names:
  • Viabahn

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Efficacy Endpoint: The Number of Patients That do Not Have a Failure of Technical Success or Loss of Primary Patency.
Time Frame: 12 months following initial study procedure
A composite of freedom from failure of technical success or loss of primary patency at 12 months
12 months following initial study procedure
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.
Time Frame: 30 days following initial study procedure
30 day serious adverse events related to the initial study procedure or the study device.
30 days following initial study procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

W.L.Gore & Associates

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

July 16, 2013

First Submitted That Met QC Criteria

July 16, 2013

First Posted (Estimate)

July 18, 2013

Study Record Updates

Last Update Posted (Estimate)

June 19, 2015

Last Update Submitted That Met QC Criteria

June 17, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAA 12-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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