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

Popliteal Artery Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02462876
• Other study ID #: FPR14-03
• Status: Completed
• Start date: October 2015
• Est. completion date: December 2020

Study information

• Verified date: March 2022
• Source: W.L.Gore & Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2020
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Popliteal Artery Aneurysm

Intervention

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

Locations

Country	Name	City	State
France	Hôpitaux Universitaire de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
W.L.Gore & Associates

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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