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

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ClinicalTrials.gov Identifier: NCT01902888
Recruitment Status : Terminated (Closed due to internal and external factors.)
First Posted : July 18, 2013
Results First Posted : June 19, 2015
Last Update Posted : June 19, 2015
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates

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
Popliteal Artery Aneurysm 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.

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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 : July 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Group/Cohort Intervention/treatment
Popliteal aneurysm
GORE® VIABAHN® Endoprosthesis used to treat popliteal aneurysm
Device: GORE® VIABAHN® Endoprosthesis
Other Name: Viabahn




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. [ 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

  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. [ Time Frame: 30 days following initial study procedure ]
    30 day serious adverse events related to the initial study procedure or the study device.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01902888


Locations
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United States, Florida
Baptist Health
Miami, Florida, United States
The Vascular Group of Naples
Naples, Florida, United States
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States
Sponsors and Collaborators
W.L.Gore & Associates
Investigators
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Study Director: Hector Novoa, BS W. L. Gore & Associates, Inc (sponsor)

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Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT01902888     History of Changes
Other Study ID Numbers: PAA 12-01
First Posted: July 18, 2013    Key Record Dates
Results First Posted: June 19, 2015
Last Update Posted: June 19, 2015
Last Verified: June 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:
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Aneurysm
Vascular Diseases
Cardiovascular Diseases