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Clinical Trial of Early Stroke Stent Device Underway

Solitaire FR Revascularization Device (Covidien)

Solitaire FR Revascularization Device (Covidien)

Covidien, a medical device company in Mansfield, Massachusetts, began enrolling paitents in a clinical trial to test its stent-based technology used with standard clot-dissolving techniques for patients in early stages of a ischemic stroke. The first of 800 patients in the trial was recruited at University at Buffalo in New York.

Ischemic stroke occurs when a blood vessel supplying blood to the brain is blocked by a blood clot, where speed of treatment is critical to preventing brain damage. The trial will test Covidien’s Solitaire FR Revascularization Device (pictured right), a wire stent that provides a temporary bypass of the blocked blood vessel and redirection of blood flow, when used as a supplement to standard clot-dissolving therapy. Standard therapies include catheters to deliver a mechanical clot-disrupting or retrieving device, or drugs known as tissue plasminogen activators — proteins that chemically dissolve blot clots.

The clinical trial will test the Solitaire device used with an intravenous tissue plasminogen activator, against the tissue plasminogen activator alone. The study plans to enroll 800 patients at 60 sites worldwide. The trial is also expected to include a health economics analysis.

The primary outcome measure for the trial is a standard assessment of disability, the modified Rankin score. Secondary outcome measures are mortality after 90 days, functional independence after 90 days as defined by the modified Rankin score, and change in the NIH Stroke Scale after 27 hours. The NIH Stroke Scale records immediate motor and cognitive symptoms of stroke.

Elad Levy, director of stroke services at University at Buffalo and Jeffrey Saver, director of UCLA’s Comprehensive Stroke Center are co-leaders of the clinical trial. Levy says the trial “is the first multi-center prospective study that studies brain physiology when selecting patients for stent retriever treatment.” Saver adds, “The goal of this international randomized trial is to demonstrate definitively the benefit of stent retriever therapy with the Solitaire FR Revascularization Device in patients with acute ischemic stroke.”

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