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

NCT02462876 | Completed Results

• 1 other identifier: FPR14-03
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Popliteal Artery Aneurysm

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Probability of Primary Patency

  12, 24, and 36 months

• Number of Subject With a Safety-related Event at 24 and 36 Months

  24 and 36 months

• Length of Hospital Stay

  During hospitalization, approximately 1-2 days

• Length of Procedure

  During procedure, approximately 120 minutes

• Probability of Primary Assisted Patency

  12, 24, and 36 months

Interventions

GORE® VIABAHN® Endoprosthesis DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• W.L.Gore & Associates: lead

Study Sites (1)

Hôpitaux Universitaire de Strasbourg

Strasbourg, France

Location

MeSH Terms

Conditions

Popliteal Artery Aneurysm

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Eric Novak
• Organization: W. L. Gore & Associates

enovak@wlgore.com

314-440-2119

Study Officials

• Nabil Chakfé

  Hôpitaux Universitaire de Strasbourg

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2015
• First Posted: June 4, 2015
• Study Start: October 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: December 1, 2020
• Last Updated: March 28, 2022
• Results First Posted: July 13, 2020

Record last verified: 2022-03

Locations

FR (1)