Evaluation of the 25 Centimeter (cm) GORE® VIABAHN® Endoprosthesis
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 Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of the 25 Centimeter (cm) GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface to Treat de Novo and/or Restenotic Lesions of the Superficial Femoral Artery (SFA)|
- Successful Completion of the Assigned Treatment [ Time Frame: Evaluated immediately after the index procedure ] [ Designated as safety issue: No ]
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.
- Device-related and Procedure-related Serious Adverse Events (SAEs) Within 30 Days of the Index Procedure [ Time Frame: 30 Days post-procedure ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||September 2015|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Experimental: 25cm Gore VIABAHN
25 cm GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface
Device: 25 cm GORE® VIABAHN®
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01263665
|Principal Investigator:||Thomas Zeller, Prof. Dr. med.||Herzzentrum Bad Krozingen|