Evaluation of the TriActiv ProGuard System During Carotid Artery Stenting

Stopped early · Phase 2/Phase 3

Conditions studied: Carotid Stenosis

In brief

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.

Key facts

Study ID

NCT00395785

Run by

Kensey Nash Corporation

People needed

400

Starts

2006-11-01

Expected to finish

2007-06-01

Last updated by the study team

2007-07-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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