Evaluation of the TriActiv ProGuard System During Carotid Artery Stenting

Phase 2

Terminated

• Conditions: Carotid Stenosis

• Registration Number: NCT00395785
• Lead Sponsor: Kensey Nash Corporation

Brief 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.

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2006-11-01
• Study First Submitted QC: 2006-11-01
• Study First Posted: 2006-11-03
• Study Completion: 2007-06
• Status Verified: 2007-07
• Last Update Submitted: 2007-07-20
• Last Update Posted: 2007-07-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
A composite of major adverse events including any death, any stroke and/or myocardial infarction through thirty days post-procedure.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (34)

University of Alabama Birmingham; 🇺🇸 Birmingham, Alabama, United States

Thomas Hospital; 🇺🇸 Fairhope, Alabama, United States

Brotman Medical Center; 🇺🇸 Beverly Hills, California, United States

Good Samaritan Hospital; 🇺🇸 Los Angeles, California, United States

El Camino Hospital; 🇺🇸 Mountain View, California, United States

Stanford University Medical Center; 🇺🇸 Stanford, California, United States

Florida Crdiovascular Research at JFK Medical Center; 🇺🇸 Atlantis, Florida, United States

University of Florida; 🇺🇸 Jacksonville, Florida, United States

Mt. Sinai Medical Center; 🇺🇸 Miami Beach, Florida, United States

Baptist Hospital of Miami; 🇺🇸 Miami, Florida, United States

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