NCT01901874

The Gore SCAFFOLD Clinical Study

GORE® Carotid Stent Clinical Study for the Treatment of Carotid Artery Stenosis in Patients at Increased Risk for Adverse Events From Carotid Endarterectomy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 312 (actual)
• Sponsor: W.L.Gore & Associates · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is a prospective, multicenter, single-arm clinical study comparing outcomes with the GORE® Carotid Stent to a performance goal derived from carotid endarterectomy outcomes in high-surgical-risk patients.

Conditions

• Carotid Artery Disease
• Carotid Artery Stenosis

Interventions

Type	Name	Description
DEVICE	Carotid Artery Stenting	Carotid Artery Stenting with the GORE® Carotid Stent

Timeline

• Start date: 2013-07-01
• Primary completion: 2017-12-01
• Completion: 2020-09-01
• First posted: 2013-07-17
• Last updated: 2020-10-29
• Results posted: 2019-05-03

Locations

2 sites across 1 country: United States