Safety and Effectiveness of an Intracranial Aneurysm Embolization System for Treating Large or Giant Wide Neck Aneurysms (SCENT)
|ClinicalTrials.gov Identifier: NCT01716117|
Recruitment Status : Active, not recruiting
First Posted : October 29, 2012
Last Update Posted : July 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Brain Aneurysm||Device: Surpass Flow Diverter||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||180 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Surpass Intracranial Aneurysm Embolization System Pivotal Trial to Treat Large or Giant Wide Neck Aneurysms (SCENT Trial)|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||July 28, 2017|
|Estimated Study Completion Date :||December 2020|
Experimental: Surpass Flow Diverter
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
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.
- Primary Effectiveness [ Time Frame: 12 months ]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 ]Percent of subjects experiencing neurologic death or major ipsilateral stroke through 12 months.
- Secondary Safety [ Time Frame: 12 months ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01716117
Show 26 Study Locations
|Principal Investigator:||Ricardo A Hanel, MD, PhD||Lyerly Baptist Medical Center, Jacksonville, Florida|
|Principal Investigator:||Philip M Meyers, MD||Columbia University|