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NCT01901874 · ClinicalTrials.gov registry record · NA
The Gore SCAFFOLD Clinical Study
A NA study of Carotid Artery Disease and Carotid Artery Stenosis, sponsored by W.L.Gore & Associates.
- Completed
- Registry status
- NA
- Development phase
- 312
- Enrollment target
- 2
- Study locations
NCT01901874: Completed NA study of Carotid Artery Disease and Carotid Artery Stenosis, sponsored by W.L.Gore & Associates.
NCT01901874 is a NA study of Carotid Artery Disease and Carotid Artery Stenosis that has completed, run by W.L.Gore & Associates. The registered enrollment target is 312 participants, below the 13,671-participant average among 5 other Carotid Artery Disease trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01901874, a NA study of Carotid Artery Disease and Carotid Artery Stenosis, has completed, sponsored by W.L.Gore & Associates.
- COMPLETED
- Registry status
- NA
- Development phase
- 312 participants
- Enrollment target
- 2
- Study locations
Study Summary
Evaluate the safety and efficacy of the GORE® Carotid Stent for the treatment of carotid artery stenosis in patients at increased risk for adverse events from carotid endarterectomy
Primary Outcome
MAE defined as any death, stroke, or myocardial infarction through 30 days post-index procedure, or ipsilateral stroke between 31 days and 1 year (365 days).
Conditions Studied
Interventions
- DEVICE Carotid Artery Stenting
Study Locations (2)
Hawaii
- Kaiser Permanente Hawaii - Honolulu
Pennsylvania
- Lankenau Heart Institute - Wynnewood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 312 participants |
| Start Date | 2013-07 |
| Est. Completion | 2020-09 |
| Phase | NA |
What the finished NCT01901874 record still lists
NCT01901874 is an interventional study that assigns participants to a tested intervention. The registered 312 participants enrollment target is mid-sized for trials with a published cap, below the 13,671-participant average among 5 other Carotid Artery Disease trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Carotid Artery Disease appearing as the primary indexed condition, and to 1 intervention - of which Carotid Artery Stenting is the first listed.
NCT01901874 reports a single indexed study location in Hawaii, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01901874 about?
NCT01901874 is a clinical study titled "The Gore SCAFFOLD Clinical Study". Evaluate the safety and efficacy of the GORE® Carotid Stent for the treatment of carotid artery stenosis in patients at increased risk for adverse events from carotid endarterectomy
What is the current status of trial NCT01901874?
This trial is currently completed. It is a NA study. The enrollment target is 312 participants. The study started on 2013-07. Estimated completion is 2020-09.
What conditions does trial NCT01901874 study?
This clinical trial studies the following conditions: Carotid Artery Disease, Carotid Artery Stenosis.
What interventions are being tested in trial NCT01901874?
The interventions under investigation include: Carotid Artery Stenting (DEVICE).
Who is sponsoring clinical trial NCT01901874?
This trial is sponsored by W.L.Gore & Associates, which has 53 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01901874 being conducted?
This trial has 2 study locations across Hawaii, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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