This study will assess the long term safety and performance of the GORE® VIABAHN® Endoprosthesis for the treatment of patients with Popliteal Artery Aneurysms.
Study Type
OBSERVATIONAL
Enrollment
60
Treatment of Popliteal Artery Aneurysm with the GORE® VIABAHN® Endoprosthesis.
Hôpitaux Universitaire de Strasbourg
Strasbourg, France
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.
Time frame: 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
Time frame: 12 months
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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: During procedure, approximately 120 minutes
Probability of Primary Assisted Patency
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Post-procedure at day 30