NCT00530504

Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,500 (actual)
• Sponsor: Medtronic Endovascular · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purposes of this study are: 1. To provide additional safety and effectiveness information on the commercial use of Protégé™ GPS™ and Protégé™ RX Carotid Stent Systems and the SpiderFX™ Embolic Protection Device. 2. To evaluate rare and unanticipated adverse events. 3. To evaluate the physician level of experience with carotid artery stenting procedures with adverse event rates.

Conditions

• Carotid Artery Disease

Interventions

Type	Name	Description
DEVICE	PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device	Carotid artery stenting with distal embolic protection.

Timeline

• Start date: 2007-05-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2007-09-17
• Last updated: 2019-03-05
• Results posted: 2015-09-16

Locations

2 sites across 1 country: United States