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

This study is currently recruiting participants.
Verified January 2014 by Stryker Neurovascular
Sponsor:
Information provided by (Responsible Party):
Stryker Neurovascular
ClinicalTrials.gov Identifier:
NCT01716117
First received: October 24, 2012
Last updated: January 24, 2014
Last verified: January 2014
  Purpose

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 our 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 Intervention
Brain Aneurysm
Device: Surpass Flow Diverter

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Stryker Neurovascular:

Primary Outcome Measures:
  • Primary Effectiveness [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

  • Primary Safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Percent of subjects experiencing neurologic death or major ipsilateral stroke through 12 months.


Secondary Outcome Measures:
  • Secondary Safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 100
Study Start Date: October 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Surpass Flow Diverter
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 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
  • Surpass NeuroEndoGraft System

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.

  Eligibility

Ages Eligible for Study:   19 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject understands the nature of the procedure and provides written informed consent
  • Subject is willing to return to the investigational site for all scheduled follow-up visits
  • Subject is 19 to 80 years of age
  • Subject has a single targeted intracranial aneurysm

Exclusion Criteria:

  • Pregnancy
  • Enrollment in another trial
  • Allergy or contraindication to aspirin, Clopidogrel/Plavix, heparin, local or general anesthesia
  • History of life threatening allergy to contrast dye
  • Major surgery within previous 30 days or planned in the next 120 days after enrollment date
  • Severe neurological deficit that renders the subject incapable of living independently
  • Dementia or psychiatric problem that prevents the patient from completing required follow up
  • Co-morbid conditions that may limit survival to less than one year
  • Subject with anatomy not appropriate for endovascular treatment due to severe intracranial vessel tortuosity or stenosis, or a 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 has a serum creatinine level greater than 2.5mg/dL (within 7 days of procedure) which the investigator determines restricts the use of contrast agents
  • Stenting, angioplasty, or endarterectomy of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days prior to treatment date
  • Subject has a previous intracranial implant associated with the symptomatic distribution within the past 12 weeks prior to treatment date
  • Subject has other known serious concurrent medical conditions such as heart disease, pulmonary disease or uncontrolled diabetes
  • Subject had a subarachnoid hemorrhage within 30 days prior to the enrollment date
  • Subject with resistance to Clopidogrel
  • Subject has a non-treated arteriovenous malformation (AVM) in the territory of the target aneurysm
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01716117

Contacts
Contact: Doug Follett, DVM, DACVA 510-413-2207 doug.follett@stryker.com
Contact: Rita Paparazzo 508-351-8632 ext 225 rpaparazzo@boston-biomedical.com

Locations
United States, Arizona
Barrows Neurological Institute Withdrawn
Phoenix, Arizona, United States, 85013
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32605
Contact: Nicolle Wilson       Nicolle.Wilson@neurosurgery.ufl.edu   
Principal Investigator: Spiros Blackburn, MD         
Sub-Investigator: Brian L Hoh, MD         
Mayo Clinic - Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Jessie Sperrazza       sperrazza.jessie@mayo.edu   
Principal Investigator: Ricardo Hanel, MD         
Sub-Investigator: Rabih G Tawk, MD         
Sub-Investigator: David A Miller, MD         
Baptist Hospital of Miami Recruiting
Miami, Florida, United States, 33176
Contact: Sarah Orendorff-Alegre       SarahO@baptisthealth.net   
Principal Investigator: Italo Linfante, MD         
Sub-Investigator: Guilherme Dabus, MD         
Tampa General Hospital Recruiting
Tampa, Florida, United States, 33606
Contact: Haydy Rojas       hrojas@tgh.org   
Principal Investigator: Peter T Kan, MD         
Sub-Investigator: Zinovy M Katz, MD         
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Christy M Anton       Christy_Anton@rush.edu   
Principal Investigator: Demetrius K Lopes, MD         
Sub-Investigator: Michael Chen, MD         
Sub-Investigator: Roham Moftakhar, MD         
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Barbara Michniewicz, RN       bwawrys1@jhmi.edu   
Principal Investigator: Alexander L Coon, MD         
Sub-Investigator: Geoffrey P Colby, MD, PhD         
Sub-Investigator: Li-mei Lin, MD         
United States, Minnesota
Mayo Clinic - Minnesota Recruiting
Rochester, Minnesota, United States, 55902
Contact: Beth Connelly, CCRP       connelly.beth@mayo.edu   
Principal Investigator: Guiseppe Lanzino, MD         
Sub-Investigator: Harry J Cloft, MD, PhD         
Sub-Investigator: David F Kallmes, MD         
United States, Missouri
Washington University Withdrawn
St Louis, Missouri, United States, 63110
United States, New York
Columbia University Recruiting
New York, New York, United States, 10032
Contact: Virginia Cox, RN       vc94@mail.cumc.columbia.edu   
Principal Investigator: Philip M Meyers, MD         
Sub-Investigator: Daniel H Sahlein, MD         
Sub-Investigator: Sean D Lavine, MD         
New York University Recruiting
New York, New York, United States, 10016
Contact: Giuseppe Agugliaro, MBA       Giuseppe.Agugliaro@nyumc.org   
Principal Investigator: Tibor Becske, MD         
Sub-Investigator: Maksim Shapiro, MD         
Sub-Investigator: Howard A Riina, MD         
Sub-Investigator: Peter K Nelson, MD         
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Sarah Jamieson       rosssar@ohsu.edu   
Principal Investigator: Stanley Barnwell, MD, PhD         
Sub-Investigator: Aclan Dogan, MD         
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Pamela Tremarki       Pamela.Tremarki@jefferson.edu   
Principal Investigator: Pascal Jabbour, MD         
Sub-Investigator: Stavropoula Tjoumakaris, MD         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29415
Contact: Adrian T Parker       parkerad@musc.edu   
Principal Investigator: Raymond D Turner, MD         
Sub-Investigator: M Imran Chaudry, MD         
Sub-Investigator: Aquilla S Turk, DO         
Sub-Investigator: Alejandro M Spiotta, MD         
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Chesney S Oravec       chesney.s.oravec@vanderbilt.edu   
Principal Investigator: J Mocco, MD, MS         
Sub-Investigator: Michael Froehler, MD, PhD         
United States, Texas
University of Texas - Southwestern Recruiting
Dallas, Texas, United States, 75390
Contact: Kim Dutton-Johnson, RN       kim.dutton@utsouthwestern.edu   
Principal Investigator: Babu Welch, MD         
Sub-Investigator: G Lee Pride, MD         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Lisa Dubler       lisa.dubler@hsc.utah.edu   
Principal Investigator: Philipp Taussky, MD         
Sub-Investigator: Edwin A Stevens, MD         
Netherlands
UMC St Radboud Recruiting
Nijmegen, Netherlands
Contact: Inge ter Horst       i.terhorst@crcn.umcn.nl   
Principal Investigator: Joost de Vries, MD, PhD         
Sub-Investigator: Hieronymus D Boogaarts, MD         
Sponsors and Collaborators
Stryker Neurovascular
Investigators
Principal Investigator: Ricardo A Hanel, MD Mayo Clinic, Jacksonville, Florida
  More Information

No publications provided

Responsible Party: Stryker Neurovascular
ClinicalTrials.gov Identifier: NCT01716117     History of Changes
Other Study ID Numbers: SP-04
Study First Received: October 24, 2012
Last Updated: January 24, 2014
Health Authority: United States: Food and Drug Administration

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014