Humanitarian Use Device: Wingspan Stent System with Gateway PTA Balloon Catheter

Service: Trial Number:
042-12
Principal Investigator: Conducted at:
Long Beach Memorial
Currently enrolling additional patients:
Yes
Age Range:
18 years & up

Cerebral ischemia (stroke or TIA [stroke]) due to intracranial stenosis (abnormal narrowing in an artery to the brain) has been demonstrated to be ineffectively treated surgically, and is often untreatable with medical therapy. The most common current method for managing intracranial stenosis is with medical therapy (medications), or the “off label” use (not specifically approved use by the FDA) of angioplasty balloons and stents (mechanical devices that help keep vessels open). There is currently no other approved method for improving the size of the artery that is providing blood to the brain when medicines are not effective. The FDA has designated the Wingspan Stent System with Gateway PTA Balloon Catheter as a Humanitarian Use Device (HUD). Use of the Wingspan Stent System and Gateway PTA Balloon Catheter provides physicians with a tool to treat these difficult lesions that were previously not available. The Wingspan Stent System will only be used clinically for its approved indication. The data will be collected only for patient care purposes and for reporting to the IRB. Subjects will be sought from the PI and Sub-Investigators’ practices. Patients are considered eligible if they present with evidence of new or recurrent stroke or TIA, refractory to medical therapy and thought to be secondary to intracranial stenosis (narrowing) >50%.

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