Safety and Effectiveness of an Intracranial Aneurysm Embolization System for Treating Large or Giant Wide Neck Aneurysms (SCENT)

December 15, 2022 updated by: Stryker Neurovascular

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
213

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
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.
12 months
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.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
12 Months
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
12 Months
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
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stryker Neurovascular

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 25, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 11, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 7, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 24, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 29, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 19, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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