Clinical trial NCT01716117: Safety and Effectiveness of an Intracranial Aneurysm Embolization System for Treating Large or Giant Wide Neck Aneurysms
Official title: The Surpass Intracranial Aneurysm Embolization System Pivotal Trial to Treat Large or Giant Wide Neck Aneurysms (SCENT Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Aneurysm
Keywords: Large aneurysm
Giant aneurysm
Wide neck aneurysm
Lead sponsor: Stryker Neurovascular
Sponsor class: INDUSTRY
First posted: 2012-10-29
Enrollment: 213
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The SCENT Trial is a multi-center, prospective, non-randomized trial.
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)
* Evidence of active infection at the time of treatment
* Dementia or psychiatric problem that prevents the patient from completing required follow up
* Co-morbid conditions that may limit survival to less than 24 months
* Serum creatinine greater or equal to 2.5 mg/dL
* Female subjects who are pregnant or planning to become pregnant within the study period
* Subject with anatomy not appropriate for endovascular treatment due to severe intracranial vessel tortuosity or stenosis
* Extra-cranial stenosis or parent vessel with stenosis greater than 50% in the area proximal to the aneurysm
* Other known serious concurrent medical conditions
* History of intracranial vasospasm not responsive to medical therapy
* Subject with an intracranial mass, or is undergoing radiation therapy for carcinoma or sarcoma of the head or neck region
* Subject has a history of bleeding diathesis or coagulopathy, international normalized ratio (INR) greater than 1.5, or will refuse blood transfusions
* Subject had a subarachnoid hemorrhage within 30 days prior to the enrollment date
* Subject has a non-treated arteriovenous malformation (AVM) in the territory of the target aneurysm
* Inability to understand the study or a history of non-compliance with medical advice
* Current use of illicit substance
* Enrollment in another trial involving an investigational product
* Subject has a need for long-term use of anticoagulants (i.e., Warfarin, Dabigatran)

Primary outcomes:
measure: 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.
timeFrame: 12 months
measure: mITT Primary Safety Endpoint. Based on Subjects Experiencing Neurologic Death or Major Ipsilateral Stroke Through 12 Month Follow-up.
timeFrame: 12 months
Secondary outcomes:
measure: Raymond-Roy Score Per Core Lab Assessment Based on Device Apposition at 12 Months Post-Procedure
timeFrame: 12 months
Other outcomes:
measure: Clinical Events Committee (CEC) Adjudicated Rate of Minor Strokes Through 12 Month Follow-Up
timeFrame: 12 Months
measure: Subgroup Analysis of Primary Effectiveness Endpoint Based on Subject Age ≥ 65 Years Versus < 65 Years in mITT Population
timeFrame: 12 Months
measure: CEC Adjudicated Primary Effectiveness Endpoint Outcomes for Giant and Non-Giant (Large) Intracranial Aneurysms Through 12 Month Follow-Up - mITT Population
timeFrame: 12 Months
measure: Number of Surpass Streamline Flow Diverters Implanted Per Subject in SCENT Trial - mITT and Roll-In Populations
timeFrame: 12 Months
Locations:
city: Irvine
country: United States
facility: University of California
state: California
city: Santa Barbara
country: United States
facility: Santa Barbara Cottage Hospital
state: California
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Jacksonville
country: United States
facility: Lyerly Neurosurgery/Baptist Health System
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic - Florida
state: Florida
city: Miami
country: United States
facility: Baptist Hospital of Miami
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Kansas City
country: United States
facility: The University of Kansas Medical Center
state: Kansas
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic - Minnesota
state: Minnesota
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Knoxville
country: United States
facility: Fort Sanders Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: University of Texas - Southwestern
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Milwaukee
country: United States
facility: The Medical College of Wisconsin
state: Wisconsin
city: Nijmegen
country: Netherlands
facility: UMC St Radboud
Study officials:
affiliation: Lyerly Baptist Medical Center, Jacksonville, Florida
name: Ricardo A Hanel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Philip M Meyers, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hanel 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.
citation: Kan 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.
citation: Meyers 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.
citation: Colby 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.