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

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ClinicalTrials.gov Identifier: NCT01716117
Recruitment Status : Active, not recruiting
First Posted : October 29, 2012
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Stryker Neurovascular

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).

Condition or disease Intervention/treatment Phase
Brain Aneurysm Device: Surpass Flow Diverter Not Applicable

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 at one year.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 : March 20, 2017
Estimated Study Completion Date : December 21, 2020

Resource links provided by the National Library of Medicine


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. This procedure is called an endovascular aneurysm treatment because the device is delivered through the blood vessels.
Other Names:
  • Flow diverter
  • Endovascular aneurysm treatment




Primary Outcome Measures :
  1. Primary Effectiveness [ 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.

  2. Primary Safety [ Time Frame: 12 months ]
    Percent of subjects experiencing neurologic death or major ipsilateral stroke through 12 months.


Secondary Outcome Measures :
  1. Secondary Safety [ Time Frame: 12 months ]
    Percent of subjects experiencing one or more serious adverse events through 12 months post-index procedure within the following two categories (as adjudicated by the Clinical Events Committee) - (1) proportion of subjects with new or worsening major ipsilateral stroke, and 2) proportion of subjects experiencing acute or subacute (< 6 weeks) thrombosis of the Surpass Implant.



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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 aneurym 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)

Information from the National Library of Medicine

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


  Hide Study Locations
Locations
United States, California
University of California
Irvine, California, United States, 92697
Santa Barbara Cottage Hospital
Santa Barbara, California, United States, 93105
United States, Florida
University of Florida
Gainesville, Florida, United States, 32611
Lyerly Neurosurgery/Baptist Health System
Jacksonville, Florida, United States, 32207
Mayo Clinic - Florida
Jacksonville, Florida, United States, 32224
Baptist Hospital of Miami
Miami, Florida, United States, 33176
Tampa General Hospital
Tampa, Florida, United States, 33606
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Kansas
The University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Massachusetts
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
United States, Minnesota
Mayo Clinic - Minnesota
Rochester, Minnesota, United States, 55902
United States, New York
University at Buffalo
Buffalo, New York, United States, 14203
Columbia University
New York, New York, United States, 10032
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Fort Sanders Medical Center
Knoxville, Tennessee, United States, 37916
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
University of Texas - Southwestern
Dallas, Texas, United States, 75390
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
United States, Wisconsin
The Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Netherlands
UMC St Radboud
Nijmegen, Netherlands
Sponsors and Collaborators
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stryker Neurovascular
ClinicalTrials.gov Identifier: NCT01716117     History of Changes
Other Study ID Numbers: SP-04
First Posted: October 29, 2012    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Stryker Neurovascular:
Large aneurysm
Giant aneurysm
Wide neck aneurysm

Additional relevant MeSH terms:
Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Calcium Carbonate
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents