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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by Stryker Neurovascular
Information provided by (Responsible Party):
Stryker Neurovascular Identifier:
First received: October 24, 2012
Last updated: November 16, 2015
Last verified: November 2015
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 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: 180
Study Start Date: October 2012
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

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

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01716117

Contact: Diana Espinoza 510-413-2158
Contact: Rita Paparazzo 508-351-8632 ext 225

  Show 31 Study Locations
Sponsors and Collaborators
Stryker Neurovascular
Principal Investigator: Ricardo A Hanel, MD, PhD Lyerly Baptist Medical Center, Jacksonville, Florida
Principal Investigator: Philip M Meyers, MD Columbia University
  More Information

No publications provided

Responsible Party: Stryker Neurovascular Identifier: NCT01716117     History of Changes
Other Study ID Numbers: SP-04
Study First Received: October 24, 2012
Last Updated: November 16, 2015
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Intracranial Aneurysm
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Intracranial Arterial Diseases
Nervous System Diseases
Vascular Diseases
Calcium Carbonate
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions processed this record on November 27, 2015