Clinical Trial Details
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[Information provided by:, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01716117 : Safety and Effectiveness of an Intracranial Aneurysm Embolization System for Treating Large or Giant Wide Neck Aneurysms
AgesMin: 19 Years Max: 80 Years
Inclusion Criteria:

- Subject understands the nature of the procedure and provides written informed consent

- Subject is willing to return to the investigational site for all scheduled follow-up

- Subject is 19 to 80 years of age

- Subject has a single targeted intracranial aneurysm

Exclusion Criteria:

- Pregnancy

- Enrollment in another trial

- Allergy or contraindication to aspirin, Clopidogrel/Plavix, heparin, local or general

- History of life threatening allergy to contrast dye

- Known allergy to nickel, chromium cobalt, tungsten or platinum.

- Major surgery within previous 30 days or planned in the next 120 days after
enrollment date

- Severe neurological deficit that renders the subject incapable of living

- Dementia or psychiatric problem that prevents the patient from completing required
follow up

- Co-morbid conditions that may limit survival to less than one year

- Subject with anatomy not appropriate for endovascular treatment due to severe
intracranial vessel tortuosity or stenosis, or a 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

- Subject has a history of bleeding diathesis or coagulopathy, international normalized
ratio (INR) greater than 1.5, or will refuse blood transfusions

- Subject has a serum creatinine level greater than 2.5mg/dL (within 7 days of
procedure) which the investigator determines restricts the use of contrast agents

- Stenting, angioplasty, or endarterectomy of an extracranial (carotid or vertebral
artery) or intracranial artery within 30 days prior to treatment date

- Subject has a previous intracranial implant associated with the symptomatic
distribution within the past 12 weeks prior to treatment date

- Subject has other known serious concurrent medical conditions such as heart disease,
pulmonary disease or uncontrolled diabetes

- Subject had a subarachnoid hemorrhage within 30 days prior to the enrollment date

- Subject with resistance to Clopidogrel

- Subject has a non-treated arteriovenous malformation (AVM) in the territory of the
target aneurysm
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