A Feasibility Study of the Surpass Aneurysm-Embolization System in Intracranial Arteries

Surpass Medical

Status and phase

Withdrawn

Phase 1

Conditions

Aneurysm

Treatments

Device: Aneurysm-Embolization System

Study type

Interventional

Funder types

Industry

Identifiers

NCT01101347

SP-03

Details and patient eligibility

About

The purpose of this study is to evaluate safety and performance of the Surpass Aneurysm-Embolization System.

Enrollment

10 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject understands the nature of the procedure and provides written informed consent.
Subject is willing to return to the investigational site for the thirty day and six month follow-up evaluations.
Age 18 years to 80 years.
Subject with a non-ruptured saccular, or fusiform intracranial aneurysm arising from a parent vessel with a diameter of > 2mm and < 6mm.

Exclusion criteria

Pregnancy
Enrollment in another trial
Allergy or contraindication to aspirin, clopidogrel, heparin, local or general anesthesia
History of life threatening allergy to contrast dye.
Major surgery within previous 30 days or planned in the next 90 days after enrollment date.
Severe neurological deficit that renders the patient incapable of living independently
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 intracranial vasospasm not responsive to medical therapy.
Subject with an intracranial mass (tumor (except meningioma), abscess, or other infection), 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 2.0 mg/dL (within 7 days of procedure) which the investigator determines restricts the use of contrast agents.
Subject has a previously implanted intracranial stent associated with the symptomatic distribution within the past 12 weeks prior to enrollment date
Stenting, angioplasty, or endarterectomy of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days prior to enrollment date
Subject has a previously implanted carotid stent associated with the symptomatic distribution within the past 12 weeks prior to enrollment date
Subject has uncontrolled atrial fibrillation or known cardiac disorders likely to be associated with cardioembolic symptoms.
Subject had a subarachnoid hemorrhage within 12 weeks prior to the enrollment date.
Subject with resistance to ASA and/or Clopidogrel.
Subject with two or more aneurysms in associated distribution - unless the device is used to treat both aneurysms.
Subject has a non-treated arteriovenous malformation (AVM) in the territory of the target aneurysm.
Target aneurysm is expected to require more than one device.