A Phase 2/3 interventional study of Carotid Stent Implantation and Embolic Protection in Carotid Stenosis, sponsored by Kensey Nash Corporation. Terminated at 34 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-07-25.
Sponsored by Kensey Nash Corporation · Phase 2/3, Interventional, and Treatment
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.
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.
349 studies on the registry are indexed under Carotid Stenosis; 82 are open to participants now.
This study's planned enrollment of 400 is above the median of 104 across 188 interventional studies indexed under Carotid Stenosis.
Browse Carotid Stenosis studies →Kensey Nash Corporation is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
This study is terminated, as verified in Jul 2007. You cannot join it, but the record below documents what was studied.
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Kensey Nash Corporation