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

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

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

Conditions
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Popliteal Artery Aneurysm

Intervention / Treatment
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* Device: GORE® VIABAHN® Endoprosthesis


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: GORE® VIABAHN® Endoprosthesis|Treatment of Popliteal Artery Aneurysm with the GORE® VIABAHN® Endoprosthesis.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Primary Patency at 12 Months | Primary Patency is defined as blood flow without occlusion maintained through the device after implant without an intervention evaluated at 12 months. | 12 months | 
| Number of Subjects With a Safety-related Event at 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 | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probability of Primary Patency | 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 | 12, 24, and 36 months | 
| Number of Subject With a Safety-related Event at 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. | 24 and 36 months | 
| Length of Hospital Stay | The number of days the subject remains in the hospital due to endovascular repair of a popliteal artery aneurysm | During hospitalization, approximately 1-2 days | 
| Length of Procedure | The number of minutes the subject remains in the operating room or catheterization laboratory due to endovascular repair of a popliteal artery aneurysm. | During procedure, approximately 120 minutes | 
| Probability of Primary Assisted Patency | 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. | 12, 24, and 36 months | 
| Probability of Freedom From Limb Loss | Limb loss is defined as the amputation of the study limb above the metatarsals. This outcome is estimated through Kaplan-Meier analysis. | 12, 24, and 36 months | 
| Probability of Freedom From Repeat Intervention | 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. | 12, 24, and 36 months | 
| Probability of Secondary Patency | 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. | 12, 24, and 36 months | 
| Number of Subjects With Technical Success | 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. | Post-procedure at day 30 |