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NCT02542267 · ClinicalTrials.gov registry record · NA
In-Stent Restenosis Post-Approval Study
A NA study, sponsored by W.L.Gore & Associates.
- Completed
- Registry status
- NA
- Development phase
- 108
- Enrollment target
NCT02542267: Completed NA study, sponsored by W.L.Gore & Associates.
NCT02542267 is a NA study that has completed, run by W.L.Gore & Associates. The registered enrollment target is 108 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02542267, a NA study, has completed, sponsored by W.L.Gore & Associates.
- COMPLETED
- Registry status
- NA
- Development phase
- 108 participants
- Enrollment target
Study Summary
The objective of the ISR 14-04 study is to evaluate post-market safety and effectiveness of GORE® VIABAHN® Endoprosthesis for treatment of In-Stent Restenosis of the Superficial Femoral Artery.
Primary Outcome
Primary Effectiveness is Primary Patency defined as patent blood flow through the study device, which requires either a Peak Systolic Velocity Ratio measurement ≤ 2.5 or patent flow indicated by the Core Lab, and without repeat intervention measured at 12 months and assessed by Kaplan-Meier analysis.
Interventions
- DEVICE Gore VIABAHN Endoprosthesis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2015-09 |
| Est. Completion | 2021-07 |
| Phase | NA |
What the finished NCT02542267 record still lists
NCT02542267 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which Gore VIABAHN Endoprosthesis is the first listed.
NCT02542267 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02542267 about?
NCT02542267 is a clinical study titled "In-Stent Restenosis Post-Approval Study". The objective of the ISR 14-04 study is to evaluate post-market safety and effectiveness of GORE® VIABAHN® Endoprosthesis for treatment of In-Stent Restenosis of the Superficial Femoral Artery.
What is the current status of trial NCT02542267?
This trial is currently completed. It is a NA study. The enrollment target is 108 participants. The study started on 2015-09. Estimated completion is 2021-07.
What interventions are being tested in trial NCT02542267?
The interventions under investigation include: Gore VIABAHN Endoprosthesis (DEVICE).
Who is sponsoring clinical trial NCT02542267?
This trial is sponsored by W.L.Gore & Associates, which has 53 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02542267's enrollment target sits among peer trials
108 825th of 2000 higher than 1,171 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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