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The Gore SCAFFOLD Clinical Study

NCT01901874 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 312

Last updated 2020-10-29

Study results available
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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

Conditions

  • Carotid Artery Disease
  • Carotid Artery Stenosis

Interventions

DEVICE

Carotid Artery Stenting

Carotid Artery Stenting with the GORE® Carotid Stent

Sponsors & Collaborators

  • W.L.Gore & Associates

    lead INDUSTRY

Principal Investigators

  • William Gray, MD · Lankenau Heart Institute

  • Peter Schneider, MD · Kaiser Health System, Honolulu

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2017-12-31
Completion
2020-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01901874 on ClinicalTrials.gov