Evaluation of GORE® VIABAHN® Endoprosthesis for Popliteal Artery Aneurysm

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.

• GORE® VIABAHN® Endoprosthesis (Device), also known as Viabahn

Primary outcomes

• 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.

Sex: All, ages: 18 Years to any

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

Participant flow

Outcome results

• Primary Efficacy Endpoint: The Number of Patients That do Not Have a Failure of Technical Success or Loss of Primary Patency. (Primary)
• 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. (Primary)

Adverse events

Limitations and caveats: Early termination of study. No subject analysis done

• Hector Novoa, BS, Study director, W. L. Gore & Associates, Inc (sponsor)