At a glance
ClinicalIndex Comparison RecordN/ACompleted· 71 enrolled
Drug / intervention
25 cm GORE® VIABAHN®device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A clinical study evaluating 25 cm GORE® VIABAHN® for Peripheral Vascular Diseases. Completed, enrolled 71 participants.
Detailed Summary
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 Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral Vascular Diseases
Countries--
Collaborators--
Timeline
N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2010
First PostedDec 2010
Primary CompletionAug 2012
Study CompletionNov 2015
TodayJul 2026
First PostedDec 21, 2010
Enrollment StartDec 1, 2010
Primary CompletionAug 1, 2012
Study CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 15.5 years ago
Interventions
25 cm GORE® VIABAHN®device
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).