Evaluation of the TriActiv ProGuard System During Carotid Artery Stenting
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 400
- 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.
- 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)
Good Samaritan Hospital
🇺🇸Los Angeles, California, United States
Baptist Hospital of Miami
🇺🇸Miami, Florida, United States
Crawford Long Hospital
🇺🇸Atlanta, Georgia, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
University of Alabama Birmingham
🇺🇸Birmingham, Alabama, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
Jewish Hospital
🇺🇸Louisville, Kentucky, United States
Florida Crdiovascular Research at JFK Medical Center
🇺🇸Atlantis, Florida, United States
El Camino Hospital
🇺🇸Mountain View, California, United States
Thomas Hospital
🇺🇸Fairhope, Alabama, United States
Brotman Medical Center
🇺🇸Beverly Hills, California, United States
Millard Fillmore Hospital
🇺🇸Buffalo, New York, United States
Millard Fillmore
🇺🇸Buffalo, New York, United States
St. John West Shore Hospital
🇺🇸Westlake, Ohio, United States
Lenox Hill Hospital
🇺🇸New York, New York, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Forsyth Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Pinnacle Health Hospital
🇺🇸Harrisburg, Pennsylvania, United States
LDS Hospital
🇺🇸Salt Lake City, Utah, United States
St. Joseph Medical Center
🇺🇸Wyomissing, Pennsylvania, United States
Baptist Hospital of East Tennessee
🇺🇸Knoxville, Tennessee, United States
Virginia Cardiovascular Specialists/St. Mary's Hospital
🇺🇸Richmond, Virginia, United States
Stadtisches Krankenhaus Neuperlach
🇩🇪Bayern, Germany
Herzzentrum Hamburg
🇩🇪Hamburg, Germany
CardioVasculares Centrum Frankfurt Sankt Katharinen
🇩🇪Frankfurt, Germany
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Mt. Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Piedmont Hospital
🇺🇸Atlanta, Georgia, United States
University of Florida
🇺🇸Jacksonville, Florida, United States
Wellmont Holston Valley Medical Center
🇺🇸Kingsport, Tennessee, United States
Lorain Community Hospital
🇺🇸Elyria, Ohio, United States
Methodist Germantown
🇺🇸Germantown, Tennessee, United States
Sisters of Charity Providence Hospital
🇺🇸Columbia, South Carolina, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States