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

Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01101347
• Other study ID #: SP-03
• Status: Withdrawn
• Phase: Phase 1
• First received: April 8, 2010
• Last updated: November 26, 2010

Study information

• Verified date: November 2010
• Source: Surpass Medical Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 10
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aneurysm

Intervention

Device:
• Aneurysm-Embolization System

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Surpass Medical Ltd.