Safety and Effectiveness of an Intracranial Aneurysm Embolization System for Treating Large or Giant Wide Neck Aneurysms

Completed · Not applicable

Conditions studied: Brain Aneurysm

In brief

This clinical research study is designed to determine safety and effectiveness of the Surpass Flow Diverter (Surpass System), an investigational device developed to treat wide-neck, large or giant intracranial aneurysms. An intracranial aneurysm is a bulge in the wall of a blood vessel in the brain. The bulge is caused by a weakening of the vessel wall. If left untreated, the bulge may continue to grow larger and ultimately the vessel may break open (rupture), resulting in serious bleeding into or around the brain. The information collected from this study will be used to evaluate how well patients do when treated with the Surpass System both immediately after treatment of an aneurysm and over a long period of time (5 years).

Key facts

Study ID

NCT01716117

Run by

Stryker Neurovascular

People needed

213

Starts

2012-10-25

Expected to finish

2022-07-07

Last updated by the study team

2022-12-19

Who can join

Age: 19 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 19 to 80 years
• Subject or legal representative is willing and able to give informed consent
• Subject has a single targeted intracranial aneurysm
• Subject agrees to return to the treating Investigator for all scheduled follow up visits and is capable of returning to the hospital for follow up

You may not qualify if…

• Known allergy or contraindication to aspirin, clopidogrel/Plavix, heparin, local or general anesthesia
• Known history of life threatening allergy to contrast dye
• Known allergy to nickel, chromium cobalt, tungsten or platinum
• Subject has documented resistance to clopidogrel/Plavix
• Major surgery within previous 30 days or planned in the next 120 days after enrollment date
• Previous intracranial implant associated with the symptomatic distribution within the past 12 weeks prior to treatment date
• Stenting, angioplasty, or endarterectomy of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days prior to treatment date
• Any previous stenting of parent artery at or proximal to the aneurysm where it would interfere with the placement and proper apposition of the device
• Any previous coiling where it would interfere with the placement and proper apposition of the device
• Platelet count less than 100,000 cells/mm3 or known platelet dysfunction
• More than one intracranial aneurysm (IA) that requires treatment within 12 months
• Asymptomatic extradural aneurysms requiring treatment
• Contraindication to CT scan or MRI
• Severe neurological deficit that renders the subject incapable of living independently
• Unstable neurological deficit (i.e., worsening of clinical condition in the last 30 days)
• Evidence of active infection at the time of treatment
• Dementia or psychiatric problem that prevents the patient from completing required follow up
• Co-morbid conditions that may limit survival to less than 24 months
• Serum creatinine greater or equal to 2.5 mg/dL
• Female subjects who are pregnant or planning to become pregnant within the study period
• Subject with anatomy not appropriate for endovascular treatment due to severe intracranial vessel tortuosity or stenosis
• Extra-cranial stenosis or parent vessel with stenosis greater than 50% in the area proximal to the aneurysm
• Other known serious concurrent medical conditions
• History of intracranial vasospasm not responsive to medical therapy
• Subject with an intracranial mass, or is undergoing radiation therapy for carcinoma or sarcoma of the head or neck region

Where it is running

• University of California — Irvine, California, United States
• Santa Barbara Cottage Hospital — Santa Barbara, California, United States
• University of Florida — Gainesville, Florida, United States
• Lyerly Neurosurgery/Baptist Health System — Jacksonville, Florida, United States
• Mayo Clinic - Florida — Jacksonville, Florida, United States
• Baptist Hospital of Miami — Miami, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• The University of Kansas Medical Center — Kansas City, Kansas, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• University of Massachusetts Medical School — Worcester, Massachusetts, United States
• Mayo Clinic - Minnesota — Rochester, Minnesota, United States
• University at Buffalo — Buffalo, New York, United States
• Columbia University — New York, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Fort Sanders Medical Center — Knoxville, Tennessee, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• University of Texas - Southwestern — Dallas, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• University of Utah — Salt Lake City, Utah, United States
• University of Virginia — Charlottesville, Virginia, United States
• The Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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