Safety and Effectiveness of an Intracranial Aneurysm Embolization System for Treating Large or Giant Wide Neck Aneurysms

Study Overview
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Brief Summary
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This clinical research study is designed to determine safety and effectiveness of the Surpass Flow Diverter (Surpass System), an investigational device developed to treat wide-neck, large or giant intracranial aneurysms. An intracranial aneurysm is a bulge in the wall of a blood vessel in the brain. The bulge is caused by a weakening of the vessel wall. If left untreated, the bulge may continue to grow larger and ultimately the vessel may break open (rupture), resulting in serious bleeding into or around the brain. The information collected from this study will be used to evaluate how well patients do when treated with the Surpass System both immediately after treatment of an aneurysm and over a long period of time (5 years).

Detailed Description
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The objective of this study is to determine safety and effectiveness of the Surpass Flow Diverter (Surpass System) in the endovascular treatment of large or giant wide-necked intracranial aneurysms in the internal carotid artery up to the terminus. The Surpass Flow Diverter is an intracranial implant designed to be placed in a parent artery so as to divert blood flow away from an aneurysm. Use of the Surpass System may be associated with a decrease in neurological death or ipsilateral stroke in patients with large or giant wide-neck aneurysms. In a given patient, the Surpass System will be deemed effective if treatment results in complete occlusion of their aneurysm without clinically significant stenosis of the parent artery, or requires retreatment of the aneurysm through 12 months.

Official Title
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The Surpass Intracranial Aneurysm Embolization System Pivotal Trial to Treat Large or Giant Wide Neck Aneurysms (SCENT Trial)

Conditions
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Brain Aneurysm

Intervention / Treatment
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* Device: Surpass Flow Diverter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 19 to 80 years Subject or legal representative is willing and able to give informed consent Subject has a single targeted intracranial aneurysm Subject agrees to return to the treating Investigator for all scheduled follow up visits and is capable of returning to the hospital for follow up Exclusion Criteria: Known allergy or contraindication to aspirin, clopidogrel/Plavix, heparin, local or general anesthesia Known history of life threatening allergy to contrast dye Known allergy to nickel, chromium cobalt, tungsten or platinum Subject has documented resistance to clopidogrel/Plavix Major surgery within previous 30 days or planned in the next 120 days after enrollment date Previous intracranial implant associated with the symptomatic distribution within the past 12 weeks prior to treatment date Stenting, angioplasty, or endarterectomy of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days prior to treatment date Any previous stenting of parent artery at or proximal to the aneurysm where it would interfere with the placement and proper apposition of the device Any previous coiling where it would interfere with the placement and proper apposition of the device Platelet count less than 100,000 cells/mm3 or known platelet dysfunction More than one intracranial aneurysm (IA) that requires treatment within 12 months Asymptomatic extradural aneurysms requiring treatment Contraindication to CT scan or MRI Severe neurological deficit that renders the subject incapable of living independently Unstable neurological deficit (i.e., worsening of clinical condition in the last 30 days) Evidence of active infection at the time of treatment Dementia or psychiatric problem that prevents the patient from completing required follow up Co-morbid conditions that may limit survival to less than 24 months Serum creatinine greater or equal to 2.5 mg/dL Female subjects who are pregnant or planning to become pregnant within the study period Subject with anatomy not appropriate for endovascular treatment due to severe intracranial vessel tortuosity or stenosis Extra-cranial stenosis or parent vessel with stenosis greater than 50% in the area proximal to the aneurysm Other known serious concurrent medical conditions 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 had a subarachnoid hemorrhage within 30 days prior to the enrollment date Subject has a non-treated arteriovenous malformation (AVM) in the territory of the target aneurysm Inability to understand the study or a history of non-compliance with medical advice Current use of illicit substance Enrollment in another trial involving an investigational product Subject has a need for long-term use of anticoagulants (i.e., Warfarin, Dabigatran)

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: The SCENT Trial is a multi-center, prospective, non-randomized trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surpass Flow Diverter<br>The objective of this study is to determine the safety and effectiveness of the Surpass Flow Diverter (Surpass System) in the endovascular treatment of large or giant wide-necked intracranial aneurysms in the internal carotid artery up to the terminus. | Device: Surpass Flow Diverter<br>* Treatment of an intracranial aneurysm involves the placement of a specially designed metallic mesh tube in a vessel in the brain where an aneurysm is located. The device looks like a fishnet sock with both ends open. Each device is delivered through a small catheter (a long, flexible tube). The catheter containing the device is inserted and advanced into a vessel in the brain. The device is then placed in the brain vessel by releasing it from the catheter. Once the device is placed inside the brain vessel, it is intended to reinforce the area of the vessel that is weakened and bulging (the aneurysm), and to cause blood to flow down the vessel and away from the aneurysm while allowing blood in the aneurysm to clot. This procedure is called an endovascular aneurysm treatment because the device is delivered through the blood vessels.<br>* Other names: Endovascular aneurysm treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mITT Primary Effectiveness Endpoint. Based on Subjects With 100% Occlusion of the Aneurysm Without Clinically Significant Stenosis of the Parent Artery, and Without Any Subsequent Treatment of the Target Aneurysm at the 12 Month Follow up Visit. | Percent of subjects with 100% occlusion of the aneurysm without clinically significant stenosis (defined as less than or equal to 50% stenosis) of the parent artery based on core lab evaluation of the 12 month follow up angiogram and without any subsequent treatment of the target aneurysm at the 12 month follow up visit. | 12 months | 
| mITT Primary Safety Endpoint. Based on Subjects Experiencing Neurologic Death or Major Ipsilateral Stroke Through 12 Month Follow-up. | Subjects experiencing neurologic death or major ipsilateral stroke through 12 months. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Raymond-Roy Score Per Core Lab Assessment Based on Device Apposition at 12 Months Post-Procedure | The Raymond-Roy intracranial aneurysm occlusion classification was used to assess the rate of aneurysm occlusion at the time of primary endpoint assessment (12 months). Occlusion rates were reported as Class I: complete obliteration (best); Class II: residual neck; Class III: residual aneurysm (worse). | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Large aneurysm, Giant aneurysm, Wide neck aneurysm