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

Phase 1

Withdrawn

• Conditions: Aneurysm

• Registration Number: NCT01101347
• Lead Sponsor: Surpass Medical Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-08
• Study First Submitted QC: 2010-04-08
• Study First Posted: 2010-04-09
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-26
• Last Update Posted: 2010-11-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP