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)

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).

Study Overview

• Status: Completed
• Conditions: Brain Aneurysm
• Intervention / Treatment: Device: Surpass Flow Diverter

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.

• Study Type: Interventional
• Enrollment (Actual): 213
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Nijmegen, Netherlands
    • UMC St Radboud
• United States
  • California
    • Irvine, California, United States, 92697
      • University of California
    • Santa Barbara, California, United States, 93105
      • Santa Barbara Cottage Hospital
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic - Florida
    • Jacksonville, Florida, United States, 32207
      • Lyerly Neurosurgery/Baptist Health System
    • Miami, Florida, United States, 33176
      • Baptist Hospital of Miami
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • The University of Kansas Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Medical School
  • Minnesota
    • Rochester, Minnesota, United States, 55902
      • Mayo Clinic - Minnesota
  • New York
    • Buffalo, New York, United States, 14203
      • University at Buffalo
    • New York, New York, United States, 10032
      • Columbia University
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Tennessee
    • Knoxville, Tennessee, United States, 37916
      • Fort Sanders Medical Center
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas - Southwestern
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • The Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.; Other Names: Flow diverter; Endovascular aneurysm treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Raymond-Roy Score Per Core Lab Assessment Based on Device Apposition at 12 Months Post-Procedure	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).	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Events Committee (CEC) Adjudicated Rate of Minor Strokes Through 12 Month Follow-Up	Patients with minor strokes through 12 months	12 Months
Subgroup Analysis of Primary Effectiveness Endpoint Based on Subject Age ≥ 65 Years Versus < 65 Years in mITT Population	Primary effectiveness by age group	12 Months
CEC Adjudicated Primary Effectiveness Endpoint Outcomes for Giant and Non-Giant (Large) Intracranial Aneurysms Through 12 Month Follow-Up - mITT Population	Primary effectiveness by intracranial aneurysm size	12 Months
Number of Surpass Streamline Flow Diverters Implanted Per Subject in SCENT Trial - mITT and Roll-In Populations	Number of devices implanted in subjects by study population	12 Months

Collaborators and Investigators

• Sponsor: Stryker Neurovascular
• Investigators: Principal Investigator: Ricardo A Hanel, MD, PhD, Lyerly Baptist Medical Center, Jacksonville, Florida; Principal Investigator: Philip M Meyers, MD, Columbia University

Publications and helpful links

General Publications

• 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. 2022 May 12:neurintsurg-2021-018189. doi: 10.1136/neurintsurg-2021-018189. Online ahead of print.
• 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.
• 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.
• 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. 2022 Nov 14:jnis-2022-019512. doi: 10.1136/jnis-2022-019512. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2012
• Primary Completion (Actual): December 11, 2016
• Study Completion (Actual): July 7, 2022

Study Registration Dates

• First Submitted: October 24, 2012
• First Submitted That Met QC Criteria: October 24, 2012
• First Posted (Estimate): October 29, 2012

Study Record Updates

• Last Update Posted (Actual): December 19, 2022
• Last Update Submitted That Met QC Criteria: December 15, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Large aneurysm; Giant aneurysm; Wide neck aneurysm
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Antacids; Calcium Carbonate
• Other Study ID Numbers: SP-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes