Evaluation of the TriActiv ProGuard System During Carotid Artery Stenting

NCT ID: NCT00395785

Last Updated: 2007-07-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2007-06-30

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.

Conditions

Carotid Stenosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Carotid Stent Implantation

Intervention Type: DEVICE

Embolic Protection

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kensey Nash Corporation

INDUSTRY

Sponsor Role: lead

Principal Investigators

Gary S Roubin, MD

Role: PRINCIPAL_INVESTIGATOR

Lenox Hill Hospital, New York, NY

Rajesh Dave, MD

Role: PRINCIPAL_INVESTIGATOR

Pinnacle Health Hospital, Harrisburg, PA

Locations

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

Baptist Hospital of Miami

Miami, Florida, United States

Mt. Sinai Medical Center

Miami Beach, Florida, United States

Piedmont Hospital

Atlanta, Georgia, United States

Crawford Long Hospital

Atlanta, Georgia, United States

Emory University Hospital

Atlanta, Georgia, United States

Jewish Hospital

Louisville, Kentucky, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Millard Fillmore Hospital

Buffalo, New York, United States

Millard Fillmore

Buffalo, New York, United States

North Shore University Hospital

Manhasset, New York, United States

Lenox Hill Hospital

New York, New York, United States

Forsyth Medical Center

Winston-Salem, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

Lorain Community Hospital

Elyria, Ohio, United States

St. John West Shore Hospital

Westlake, Ohio, United States

Pinnacle Health Hospital

Harrisburg, Pennsylvania, United States

St. Joseph Medical Center

Wyomissing, Pennsylvania, United States

Sisters of Charity Providence Hospital

Columbia, South Carolina, United States

Methodist Germantown

Germantown, Tennessee, United States

Wellmont Holston Valley Medical Center

Kingsport, Tennessee, United States

Baptist Hospital of East Tennessee

Knoxville, Tennessee, United States

LDS Hospital

Salt Lake City, Utah, United States

Virginia Cardiovascular Specialists/St. Mary's Hospital

Richmond, Virginia, United States

Stadtisches Krankenhaus Neuperlach

Bayern, , Germany

CardioVasculares Centrum Frankfurt Sankt Katharinen

Frankfurt, , Germany

Herzzentrum Hamburg

Hamburg, , Germany

Countries

United States; Germany

Other Identifiers

PROGUARD

Identifier Type: -

Identifier Source: org_study_id