Cedars-Sinai investigators are spearheading a national study testing the Wingspan Stent System for patients diagnosed with severe intracranial stenosis and to whom medical management is no longer an effective option.
The Wingspan Stent System Post Market Surveillance Study, or WEAVE, is evaluating whether the system is capable of reducing risk of recurrent strokes in patients with intracranial atherosclerotic diseases. WEAVE will evaluate the rate of stroke and/or death at 72-hours post-procedure in patients treated with the system according to indications for use.
"Most experts believe stenting is a valuable option for patients with severe blockages," said Michael Alexander, MD, director of the Neurovascular Center at Cedars-Sinai and principal investigator for the national study. "We have had many patients who have had dramatic, immediate improvement in neurological function following intracranial stenting. This option, if proven successful in this study, has the potential of becoming a major advance for patients who, in the past, only had the option of taking medication and still faced a high recurrent stroke rate."
Made by medical technology company Stryker and approved by the U.S. Food and Drug Administration under the Humanitarian Device Exemption, the Wingspan Stent System combines a percutaneous transluminal angioplasty (PTA) balloon catheter with a self-expanding neurovascular, nitinol stent and stent delivery system.
It is used to open narrow arteries in the brains of patients with severe intracranial atherosclerotic disease who have failed medical therapy in intracranial vessels. These patients are at extreme risk for recurrent strokes due to reduced blood flow to the brain from narrowed or blocked arteries.
Investigators are currently recruiting patients for the WEAVE trial at 28 sites nationwide, including at Cedars-Sinai. Patients eligible for the trial include those between the ages of 22 and 80 and who are eligible for treatment with the Wingspan Stent System. These patients also have recurrent (two or more) strokes refractory to a comprehensive regimen of medical therapy and due to atherosclerotic disease of intracranial vessels with 70-99 percent stenosis.