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

NCT ID: NCT01101347

Last Updated: 2010-11-30

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL

Brief Summary

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

Conditions

Aneurysm

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Aneurysm-Embolization System

Group Type: EXPERIMENTAL

Aneurysm-Embolization System

Intervention Type: DEVICE

Interventions

Aneurysm-Embolization System

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Surpass Medical Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Surpass Medical, Ltd

Principal Investigators

Vipul Gupta, MD

Role: PRINCIPAL_INVESTIGATOR

Medanta, Medcity

Countries

India

Other Identifiers

SP-03

Identifier Type: -

Identifier Source: org_study_id