Evaluation of the TriActiv ProGuard System During Carotid Artery Stenting

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Carotid Stenosis

Intervention / Treatment
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* Device: Carotid Stent Implantation
* Device: Embolic Protection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Greater than 18 year of age Patient gives informed consent Less than 30mm stenosis in the common and/or internal carotid artery: at least a 50% stenosis if symptomatic or at least an 80% stenosis if asymptomatic At least one medical or anatomic condition which makes the patient a high surgical risk. Exclusion Criteria: Stroke within 14 days Major stroke with significant residual effects Myocardial infarction within 72 hours Extensive atherosclerotic disease in the aortic arch or proximal common carotid artery Severe carotid artery tortuosity Total occlusion Presence of thrombus or heavy calcification in the carotid artery Pre-existing carotid artery dissection Any planned interventional or surgical procedures within 30 days Atrial fibrillation Creatinine > 2 mg/dL Current participation in another investigational drug or device study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Carotid Stent Implantation|nan|
|Device: Embolic Protection|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A composite of major adverse events including any death, any stroke and/or myocardial infarction through thirty days post-procedure. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Embolic protection, Carotid stenosis, Intracranial Embolism, Carotid artery, Carotid stent, TriActiv ProGuard System, Carotid angioplasty