Safety and Effectiveness of an Intracranial Aneurysm Embolization System for Treating Large or Giant Wide Neck Aneurysms (SCENT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01716117|
Recruitment Status : Completed
First Posted : October 29, 2012
Results First Posted : July 23, 2019
Last Update Posted : December 19, 2022
|Condition or disease||Intervention/treatment||Phase|
|Brain Aneurysm||Device: Surpass Flow Diverter||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||213 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||The SCENT Trial is a multi-center, prospective, non-randomized trial.|
|Masking:||None (Open Label)|
|Official Title:||The Surpass Intracranial Aneurysm Embolization System Pivotal Trial to Treat Large or Giant Wide Neck Aneurysms (SCENT Trial)|
|Actual Study Start Date :||October 25, 2012|
|Actual Primary Completion Date :||December 11, 2016|
|Actual Study Completion Date :||July 7, 2022|
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 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.
- 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. [ 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.
- mITT Primary Safety Endpoint. Based on Subjects Experiencing Neurologic Death or Major Ipsilateral Stroke Through 12 Month Follow-up. [ Time Frame: 12 months ]Subjects experiencing neurologic death or major ipsilateral stroke through 12 months.
- Raymond-Roy Score Per Core Lab Assessment Based on Device Apposition at 12 Months Post-Procedure [ Time Frame: 12 months ]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).
- Clinical Events Committee (CEC) Adjudicated Rate of Minor Strokes Through 12 Month Follow-Up [ Time Frame: 12 Months ]Patients with minor strokes through 12 months
- Subgroup Analysis of Primary Effectiveness Endpoint Based on Subject Age ≥ 65 Years Versus < 65 Years in mITT Population [ Time Frame: 12 Months ]Primary effectiveness by age group
- CEC Adjudicated Primary Effectiveness Endpoint Outcomes for Giant and Non-Giant (Large) Intracranial Aneurysms Through 12 Month Follow-Up - mITT Population [ Time Frame: 12 Months ]Primary effectiveness by intracranial aneurysm size
- Number of Surpass Streamline Flow Diverters Implanted Per Subject in SCENT Trial - mITT and Roll-In Populations [ Time Frame: 12 Months ]Number of devices implanted in subjects by study population
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01716117
|Principal Investigator:||Ricardo A Hanel, MD, PhD||Lyerly Baptist Medical Center, Jacksonville, Florida|
|Principal Investigator:||Philip M Meyers, MD||Columbia University|