Safety and Effectiveness of an Intracranial Aneurysm Embolization System for Treating Large or Giant Wide Neck Aneurysms
SCENT
The Surpass Intracranial Aneurysm Embolization System Pivotal Trial to Treat Large or Giant Wide Neck Aneurysms (SCENT Trial)
1 other identifier
interventional
213
2 countries
26
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2012
Longer than P75 for not_applicable
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2012
CompletedStudy Start
First participant enrolled
October 25, 2012
CompletedFirst Posted
Study publicly available on registry
October 29, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 11, 2016
CompletedResults Posted
Study results publicly available
July 23, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 7, 2022
CompletedDecember 19, 2022
December 1, 2022
4.1 years
October 24, 2012
May 17, 2019
December 15, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Raymond-Roy Score Per Core Lab Assessment Based on Device Apposition at 12 Months Post-Procedure
12 months
Other Outcomes (4)
Clinical Events Committee (CEC) Adjudicated Rate of Minor Strokes Through 12 Month Follow-Up
12 Months
Subgroup Analysis of Primary Effectiveness Endpoint Based on Subject Age ≥ 65 Years Versus < 65 Years in mITT Population
12 Months
CEC Adjudicated Primary Effectiveness Endpoint Outcomes for Giant and Non-Giant (Large) Intracranial Aneurysms Through 12 Month Follow-Up - mITT Population
12 Months
- +1 more other outcomes
Study Arms (1)
Surpass Flow Diverter
EXPERIMENTALThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
University of California
Irvine, California, 92697, United States
Santa Barbara Cottage Hospital
Santa Barbara, California, 93105, United States
University of Florida
Gainesville, Florida, 32611, United States
Lyerly Neurosurgery/Baptist Health System
Jacksonville, Florida, 32207, United States
Mayo Clinic - Florida
Jacksonville, Florida, 32224, United States
Baptist Hospital of Miami
Miami, Florida, 33176, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
The University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Johns Hopkins University
Baltimore, Maryland, 21287, United States
University of Massachusetts Medical School
Worcester, Massachusetts, 01655, United States
Mayo Clinic - Minnesota
Rochester, Minnesota, 55902, United States
University at Buffalo
Buffalo, New York, 14203, United States
Columbia University
New York, New York, 10032, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Fort Sanders Medical Center
Knoxville, Tennessee, 37916, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
University of Texas - Southwestern
Dallas, Texas, 75390, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
University of Utah
Salt Lake City, Utah, 84132, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
UMC St Radboud
Nijmegen, Netherlands
Related Publications (5)
Meyers PM, Coon AL, Kan P, Dogan A, Bain M, Welch BG, Ebersole K, De Vries J, Wakhloo AK, Taussky P, Jenkins P, Hanel RA; SCENT Investigators. Five-year results of the SCENT trial with Surpass flow diverters to treat large or giant wide-neck aneurysms. J Neurointerv Surg. 2025 Sep 12;17(10):1078-1082. doi: 10.1136/jnis-2024-022977.
PMID: 40335285DERIVEDHanel RA, Cortez GM, Coon AL, Kan P, Taussky P, Wakhloo AK, Welch BG, Dogan A, Bain M, De Vries J, Ebersole K, Meyers PM; SCENT Investigator Group. Surpass Intracranial Aneurysm Embolization System Pivotal Trial to Treat Large or Giant Wide-Neck Aneurysms - SCENT: 3-year outcomes. J Neurointerv Surg. 2023 Nov;15(11):1084-1089. doi: 10.1136/jnis-2022-019512. Epub 2022 Nov 14.
PMID: 36375835DERIVEDKan P, Mohanty A, Meyers PM, Coon AL, Wakhloo AK, Marosfoi M, Bain M, de Vries J, Ebersole K, Lanzino G, Taussky P, Hanel RA. Treatment of large and giant posterior communicating artery aneurysms with the Surpass streamline flow diverter: results from the SCENT trial. J Neurointerv Surg. 2023 Jul;15(7):679-683. doi: 10.1136/neurintsurg-2021-018189. Epub 2022 May 12.
PMID: 35551072DERIVEDMeyers PM, Coon AL, Kan PT, Wakhloo AK, Hanel RA. SCENT Trial. Stroke. 2019 Jun;50(6):1473-1479. doi: 10.1161/STROKEAHA.118.024135. Epub 2019 May 14.
PMID: 31084335DERIVEDColby GP, Lin LM, Caplan JM, Jiang B, Michniewicz B, Huang J, Tamargo RJ, Coon AL. Flow diversion of large internal carotid artery aneurysms with the surpass device: impressions and technical nuance from the initial North American experience. J Neurointerv Surg. 2016 Mar;8(3):279-86. doi: 10.1136/neurintsurg-2015-011769. Epub 2015 May 18.
PMID: 25987590DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Scott Courts, Clinical Program Manager
- Organization
- Stryker Neurovascular
Study Officials
- PRINCIPAL INVESTIGATOR
Ricardo A Hanel, MD, PhD
Lyerly Baptist Medical Center, Jacksonville, Florida
- PRINCIPAL INVESTIGATOR
Philip M Meyers, MD
Columbia University
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2012
First Posted
October 29, 2012
Study Start
October 25, 2012
Primary Completion
December 11, 2016
Study Completion
July 7, 2022
Last Updated
December 19, 2022
Results First Posted
July 23, 2019
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share
There is no plan to make IPD information available to other researchers. Blinded study data by mITT and Roll-in cohorts may be made available to SCENT researchers post publication of the primary study results.