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

Completed

Conditions: Popliteal Artery Aneurysm

Registration Number: NCT02462876

Lead Sponsor: W.L.Gore & Associates

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 60

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.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Probability of Freedom From Repeat Intervention	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.
Length of Hospital Stay	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
Probability of Primary Assisted Patency	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.
Probability of Secondary Patency	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.
Number of Subjects With Technical Success	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.
Number of Subject With a Safety-related Event at 24 and 36 Months	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.
Length of Procedure	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.
Probability of Primary Patency	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
Probability of Freedom From Limb Loss	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.