NCT00395785

Evaluation of the TriActiv ProGuard System During Carotid Artery Stenting

Protection During Carotid Stenting in High Risk Patients With the TriActiv ProGuard System

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Kensey Nash Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of the TriActiv® ProGuard™ System when used during a stent placement in a blockage within the carotid artery in patients considered to be at high risk for complications from surgical endarterectomy.

Detailed description

Patients with certain anatomic or medical conditions have a greater risk of serious complications following carotid endarterectomy (a surgical procedure that removes blockages in the carotid artery). Recently, these patients have been treated effectively with the implantation of a carotid stent (a metallic mesh tube). When implanting the carotid stent, physicians use devices called embolic protection devices to prevent particles from the blockage from flowing up to the brain. The TriActiv® ProGuard™ System is an embolic protection device that uses a small balloon to temporarily stop blood flow within the diseased carotid artery while the stent is implanted. Then, the TriActiv® ProGuard™ System removes any particles that may have been released from the blockage during stent implantation before blood flow is restored. This study will evaluate the safety and efficacy of the TriActiv® ProGuard™ System during carotid stent placement in patients who are considered to be at a high risk for complications from surgical endarterectomy.

Conditions

• Carotid Stenosis

Interventions

Type	Name	Description
DEVICE	Carotid Stent Implantation
DEVICE	Embolic Protection

Timeline

• Start date: 2006-11-01
• Completion: 2007-06-01
• First posted: 2006-11-03
• Last updated: 2007-07-25

Locations

34 sites across 2 countries: United States, Germany