Safety and Effectiveness of an Intracranial Aneurysm Embolization System for Treating Large or Giant Wide Neck Aneurysms
Condition: Brain Aneurysm
MeSH terms: Intracranial Aneurysm; Aneurysm
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): Surpass Flow Diverter
Intervention type(s): Device
Intervention description(s): 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.
Other intervention name(s): Flow diverter; Endovascular aneurysm treatment
Intervention MeSH terms: Calcium Carbonate
Intervention model: Single Group Assignment
Intervention model description: The SCENT Trial is a multi-center, prospective, non-randomized trial.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Large aneurysm; Giant aneurysm; Wide neck aneurysm