Evaluation of GORE® VIABAHN® Endoprosthesis for Popliteal Artery Aneurysm

Terminated

• Conditions: Popliteal Artery Aneurysm

• Registration Number: NCT01902888
• Lead Sponsor: W.L.Gore & Associates

Brief Summary

This is a multicenter, non-randomized, single arm, retrospective study of GORE® VIABAHN® Endoprosthesis for the treatment of a Popliteal Artery Aneurysm (PAA).

Detailed Description

The primary objective is to evaluate the safety and efficacy of the GORE® VIABAHN® Endoprosthesis for the treatment of subjects with Popliteal Artery Aneurysms. The study population includes subjects with an asymptomatic aneurysm (≥ 2 cm diameter) of the popliteal artery, symptomatic aneurysm (no diameter requirement) of the popliteal artery, or presence of mural thrombus (no diameter requirement) of the popliteal artery treated with the GORE® VIABAHN® Endoprosthesis between January 1, 2002 and December 31, 2010. Starting with most recently treated within the above date range, patients meeting Inclusion/Exclusion will be enrolled, until a minimum of 50 subjects with adequate follow up to determine primary endpoints through 12 months will be provided.

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-16
• Study First Submitted QC: 2013-07-16
• Study First Posted: 2013-07-18
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Results First Submitted: 2015-05-19
• Status Verified: 2015-06
• Results First Submitted QC: 2015-06-17
• Last Update Submitted: 2015-06-17
• Results First Posted: 2015-06-19
• Last Update Posted: 2015-06-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• Received a GORE® VIABAHN® Endoprosthesis between January 1, 2002 and December 31, 2010 to treat a popliteal artery aneurysm;
• Had an asymptomatic aneurysm (≥ 2 cm diameter) of the popliteal artery, or symptomatic aneurysm (no diameter requirement) of the popliteal artery, or the presence of mural thrombus (no diameter requirement) of the popliteal artery;
• Was 18 years of age or older; and
• Had an elective popliteal artery aneurysm procedure.

Exclusion Criteria

• Bilateral popliteal artery aneurysms with initial treatment on the same day
• 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
Primary Efficacy Endpoint: The Number of Patients That do Not Have a Failure of Technical Success or Loss of Primary Patency.	12 months following initial study procedure	A composite of freedom from failure of technical success or loss of primary patency at 12 months
Primary Safety Endpoint: Number of Serious Adverse Events (Related to Initial Procedure or the Device Itself) That Occur Within 30 Days of the Initial Study Procedure.	30 days following initial study procedure	30 day serious adverse events related to the initial study procedure or the study device.

Trial Locations

Locations (3)

Baptist Health; 🇺🇸 Miami, Florida, United States

The Vascular Group of Naples; 🇺🇸 Naples, Florida, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States