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

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

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 Overview

• Status: Completed
• Conditions: Popliteal Artery Aneurysm
• Intervention / Treatment: Device: GORE® VIABAHN® Endoprosthesis

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• France
  • Strasbourg, France
    • Hopitaux Universitaire de Strasbourg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with a symptomatic aneurysm or asymptomatic aneurysm (≥ 2 cm diameter) of the popliteal artery, or presence of mural thrombus (< 2 cm) in the popliteal artery treated since the date of reimbursement in France.

Description

Inclusion Criteria:

Inclusion to the study requires the patient:

1. Received a GORE® VIABAHN® Endoprosthesis to treat a popliteal artery aneurysm
2. 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;
3. Was 18 years of age or older at the time of the treatment;
4. Had an elective popliteal artery aneurysm procedure;
5. 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:

1. Bilateral popliteal artery aneurysms with initial treatment on the same day;
2. Thrombotic occlusion of the popliteal artery or PAA;
3. Marfan syndrome or Ehlers-Danlos syndrome;
4. Unable to tolerate antiplatelet therapy;
5. Thrombophilia requiring long term anticoagulation;
6. Known allergies to the GORE® VIABAHN® Endoprosthesis components;
7. 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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: W.L.Gore & Associates
• Investigators: Principal Investigator: Nabil Chakfé, Hopitaux Universitaire de Strasbourg

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: May 29, 2015
• First Submitted That Met QC Criteria: June 1, 2015
• First Posted (Estimate): June 4, 2015

Study Record Updates

• Last Update Posted (Actual): March 28, 2022
• Last Update Submitted That Met QC Criteria: March 1, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm
• Other Study ID Numbers: FPR14-03