Evaluation of GORE® VIABAHN® Endoprosthesis for Popliteal Artery Aneurysm — PAA 12-01  

Popliteal Artery Aneurysm Clinical Trial

Official title: Retrospective Evaluation of the GORE® VIABAHN® Endoprosthesis for a Popliteal Artery Aneurysm Indication

Status Terminated

Clinical Trial Summary

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

Clinical Trial 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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Aneurysm
• Popliteal Artery Aneurysm

• NCT number: NCT01902888
• Study type: Observational
• Source: W.L.Gore & Associates
• Status: Terminated
• Phase: N/A
• Start date: July 2013
• Completion date: April 2014