Evaluation of the TriActiv ProGuard System During Carotid Artery Stenting
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.
Device: Carotid Stent Implantation
Device: Embolic Protection
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Protection During Carotid Stenting in High Risk Patients With the TriActiv ProGuard System|
- A composite of major adverse events including any death, any stroke and/or myocardial infarction through thirty days post-procedure.
- Rate of subject intolerance to prolonged carotid artery occlusion;
- Rate of access site complications requiring treatment with blood transfusion or surgical repair.
- Rate of successful use of the study device success
- Rate of successful lesion treatment
- Rate of procedure success
|Study Start Date:||November 2006|
|Study Completion Date:||June 2007|
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.
Show 34 Study Locations
|Principal Investigator:||Gary S Roubin, MD||Lenox Hill Hospital, New York, NY|
|Principal Investigator:||Rajesh Dave, MD||Pinnacle Health Hospital, Harrisburg, PA|