The purpose of this study is to confirm the safety and performance of the 25 cm GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface when used in the Superficial Femoral Artery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
71
25 cm GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface, possibly in conjunction with an additional overlapping VIABAHN® device (2.5, 5, 10, 15, or 25 cm lengths) based on the enrolled patient's lesion length (greater than or equal to 20 cm length).
Successful Completion of the Assigned Treatment
Successful completion of the assigned treatment and postdeployment\> stent length (of the first deployed 25 cm GORE\> VIABAHN Endoprosthesis with PROPATEN Bioactive Surface)\> being within 10% of pre-deployment stent length.
Time frame: Evaluated immediately after the index procedure
Device-related and Procedure-related Serious Adverse Events (SAEs) Within 30 Days of the Index Procedure
Time frame: 30 Days post-procedure
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