Safety and Effectiveness of an Intracranial Aneurysm Embolization System for Treating Large or Giant Wide Neck Aneurysms (SCENT)
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 our 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).
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Surpass Intracranial Aneurysm Embolization System Pivotal Trial to Treat Large or Giant Wide Neck Aneurysms (SCENT Trial)|
- Primary Effectiveness [ Time Frame: 12 months ] [ Designated as safety issue: No ]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.
- Primary Safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Percent of subjects experiencing neurologic death or major ipsilateral stroke through 12 months.
- Secondary Safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Percent of subjects experiencing one or more serious adverse events through 12 months post-index procedure within the following two categories (as adjudicated by the Clinical Events Committee) - (1) proportion of subjects with new or worsening major ipsilateral stroke, and 2) proportion of subjects experiencing acute or subacute (< 6 weeks) thrombosis of the Surpass Implant.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||December 2018|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Surpass Flow Diverter
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 internal carotid artery up to the terminus.
Device: Surpass Flow Diverter
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. This procedure is called an endovascular aneurysm treatment because the device is delivered through the blood vessels.
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 at one year.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01716117
|Contact: Diana Espinozafirstname.lastname@example.org|
|Contact: Rita Paparazzo||508-351-8632 ext email@example.com|
Show 25 Study Locations
|Principal Investigator:||Ricardo A Hanel, MD||Lyerly Baptist Medical Center, Jacksonville, Florida|