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Completed

NCT Number: NCT02462876

Evaluation of the GORE® VIABAHN® Endoprosthesis for the Treatment of Popliteal Artery Aneurysm (PAA)

This study will assess the long term safety and performance of the GORE® VIABAHN® Endoprosthesis for the treatment of patients with Popliteal Artery Aneurysms.

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Key information

Conditions

Popliteal Artery Aneurysm Aneurysm Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpitaux Universitaire de Strasbourg

Strasbourg, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion to the study requires the patient:

  • Received a GORE® VIABAHN® Endoprosthesis to treat a popliteal artery aneurysm
  • Had a symptomatic aneurysm or asymptomatic aneurysm (≥ 2 cm diameter) of the popliteal artery, or the presence of mural thrombus (< 2 cm) in the popliteal artery;
  • Was 18 years of age or older at the time of the treatment;
  • Had an elective popliteal artery aneurysm procedure;
  • Has provided Informed Consent, personally or through lawful representation as determined by applicable local regulations and state law

Exclusion criteria

Prior to or at the time of implant the patient is / has:

  • Bilateral popliteal artery aneurysms with initial treatment on the same day;
  • Thrombotic occlusion of the popliteal artery or PAA;
  • Marfan syndrome or Ehlers-Danlos syndrome;
  • Unable to tolerate antiplatelet therapy;
  • Thrombophilia requiring long term anticoagulation;
  • Known allergies to the GORE® VIABAHN® Endoprosthesis components;
  • Enrolled in another investigational drug or medical device trial where participation may have affected the outcome or treatment of the subject in the popliteal artery aneurysm study with the GORE® VIABAHN® Endoprosthesis or had previous surgery for the popliteal artery aneurysm in the study limb.

Treatment and study plan

GORE® VIABAHN® Endoprosthesis

Device

Treatment of Popliteal Artery Aneurysm with the GORE® VIABAHN® Endoprosthesis.

Primary outcomes

  1. Number of Subjects With Primary Patency at 12 Months

    Time frame: 12 months

    Primary Patency is defined as blood flow without occlusion maintained through the device after implant without an intervention evaluated at 12 months.

  2. Number of Subjects With a Safety-related Event at 12 Months

    Time frame: 12 months

    Safety-related events are defined as serious adverse events and adverse events related to the study procedure or the study device through 12 months

Secondary outcomes

  1. Probability of Primary Patency

    Time frame: 12, 24, and 36 months

    Primary patency is defined as blood flow without occlusion maintained through the device after implant without an intervention. This outcome is estimated through Kaplan-Meier analysis

  2. Number of Subject With a Safety-related Event at 24 and 36 Months

    Time frame: 24 and 36 months

    Safety-related events are defined as serious adverse events and adverse events related to study procedure or study device through 24 and 36 months.

  3. Length of Hospital Stay

    Time frame: During hospitalization, approximately 1-2 days

    The number of days the subject remains in the hospital due to endovascular repair of a popliteal artery aneurysm

  4. Length of Procedure

    Time frame: During procedure, approximately 120 minutes

    The number of minutes the subject remains in the operating room or catheterization laboratory due to endovascular repair of a popliteal artery aneurysm.

  5. Probability of Primary Assisted Patency

    Time frame: 12, 24, and 36 months

    Primary assisted patency is defined as blood flow maintained through the device after implant regardless of repeat interventions performed (without occlusion). This outcome is estimated through Kaplan-Meier analysis.

  6. Probability of Freedom From Limb Loss

    Time frame: 12, 24, and 36 months

    Limb loss is defined as the amputation of the study limb above the metatarsals. This outcome is estimated through Kaplan-Meier analysis.

  7. Probability of Freedom From Repeat Intervention

    Time frame: 12, 24, and 36 months

    Repeat Intervention is defined as any endovascular or surgical procedure performed to treat a stenosis or occlusion with the study device(s) or within 5 millimeters of the proximal or distal edge of the device(s), treatment of endoleaks or other reasons. This outcome is estimated through Kaplan-Meier analysis.

  8. Probability of Secondary Patency

    Time frame: 12, 24, and 36 months

    Secondary patency is defined as blood flow through the device regardless of repeat interventions performed (with or without occlusion) and freedom from surgical bypass. This outcome is estimated through Kaplan-Meier analysis.

  9. Number of Subjects With Technical Success

    Time frame: Post-procedure at day 30

    Technical success is defined as successful aneurysmal exclusion using the study device at time of the procedure without Type I or III endoleaks that require post-procedure intervention within 30 days.

Sponsors and collaborators

Lead sponsor

W.L.Gore & Associates

Industry

Registry information

Official study title

Post-market Study: Evaluation of the GORE® VIABAHN® Endoprosthesis for the Treatment of Popliteal Artery Aneurysm

Important dates

Study start
2015
Primary completion
2018
Study completion
2020
First posted
Jun 4, 2015
Registry last updated
Mar 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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