NCT00402740

Protected Carotid Artery Stenting in Subjects at High Risk for Carotid Endarterectomy (CEA) (PROTECT)

Protected Carotid Artery Stenting in Subjects at High Risk for Carotid Endarterectomy (CEA)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 322 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the long-term safety and efficacy of the Xact™ Rapid Exchange Carotid Stent System used in conjunction with the Emboshield® Pro Rapid Exchange Embolic Protection System (Generation 5) and the Emboshield® BareWire™ Rapid Exchange Embolic Protection System (Generation 3), in the treatment of atherosclerotic carotid artery disease in high-surgical risk subjects.

Conditions

• Carotid Artery Disease

Interventions

Type	Name	Description
DEVICE	Xact Stent with either Emboshield Pro (Gen 5) or Emboshield (Gen 3)	All subjects will receive the Xact™ Rapid Exchange Carotid Stent System. The first 220 consecutively enrolled subjects will be treated with the investigational filter system, the Emboshield® Pro Rapid Exchange Embolic Protection System (Generation 5). The remaining subjects will be treated with the FDA approved Emboshield® BareWire™ Rapid Exchange Embolic Protection System (Generation 3).

Timeline

• Start date: 2006-11-01
• Primary completion: 2011-06-01
• Completion: 2011-10-01
• First posted: 2006-11-22
• Last updated: 2012-06-20
• Results posted: 2012-06-20

Locations

38 sites across 1 country: United States