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Home » Clinical Trials » Aneurysm

Clinical Trial Details

Overview

Research Study Summary

A clinical study for patients with Brain Aneurysm

Research Study Title

The Surpass Intracranial Aneurysm Embolization System Pivotal Trial to Treat Large or Giant Wide Neck Aneurysms (SCENT Trial)

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).

To Learn more
Gender

Both Male and Female

Age

19 to 80 Years

Overall Status

Recruiting

Lead Sponsor

Stryker Neurovascular

Duration

26 Months

Facility Type

N/A

Eligibility

Both Male and Female ages 19 Years to 80 Years

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

Site Locations (16)

Country State City Zip Facility and Contact
United States Florida Gainesville 32605 University of Florida
Nicolle Wilson
Nicolle.Wilson@neurosurgery.ufl.edu

Spiros Blackburn, MD
Principal Investigator

Brian L Hoh, MD
Sub-Investigator
United States Florida Jacksonville 32224 Mayo Clinic - Florida
Jessie Sperrazza
sperrazza.jessie@mayo.edu

Ricardo Hanel, MD
Principal Investigator

Rabih G Tawk, MD
Sub-Investigator

David A Miller, MD
Sub-Investigator
United States Florida Miami 33176 Baptist Hospital of Miami
Sarah Orendorff-Alegre
SarahO@baptisthealth.net

Italo Linfante, MD
Principal Investigator

Guilherme Dabus, MD
Sub-Investigator
United States Florida Tampa 33606 Tampa General Hospital
Haydy Rojas
hrojas@tgh.org

Peter T Kan, MD
Principal Investigator

Zinovy M Katz, MD
Sub-Investigator
United States Illinois Chicago 60612 Rush University Medical Center
Christy M Anton
Christy_Anton@rush.edu

Demetrius K Lopes, MD
Principal Investigator

Michael Chen, MD
Sub-Investigator

Roham Moftakhar, MD
Sub-Investigator
United States Maryland Baltimore 21287 Johns Hopkins University
Barbara Michniewicz, RN
bwawrys1@jhmi.edu

Alexander L Coon, MD
Principal Investigator

Geoffrey P Colby, MD, PhD
Sub-Investigator

Li-mei Lin, MD
Sub-Investigator
United States Minnesota Rochester 55902 Mayo Clinic - Minnesota
Beth Connelly, CCRP
connelly.beth@mayo.edu

Guiseppe Lanzino, MD
Principal Investigator

Harry J Cloft, MD, PhD
Sub-Investigator

David F Kallmes, MD
Sub-Investigator
United States New York New York 10032 Columbia University
Virginia Cox, RN
vc94@mail.cumc.columbia.edu

Philip M Meyers, MD
Principal Investigator

Daniel H Sahlein, MD
Sub-Investigator

Sean D Lavine, MD
Sub-Investigator
United States New York New York 10016 New York University
Giuseppe Agugliaro, MBA
Giuseppe.Agugliaro@nyumc.org

Tibor Becske, MD
Principal Investigator

Maksim Shapiro, MD
Sub-Investigator

Howard A Riina, MD
Sub-Investigator

Peter K Nelson, MD
Sub-Investigator
United States Oregon Portland 97239 Oregon Health and Science University
Sarah Jamieson
rosssar@ohsu.edu

Stanley Barnwell, MD, PhD
Principal Investigator

Aclan Dogan, MD
Sub-Investigator
United States Pennsylvania Philadelphia 19107 Thomas Jefferson University
Pamela Tremarki
Pamela.Tremarki@jefferson.edu

Pascal Jabbour, MD
Principal Investigator

Stavropoula Tjoumakaris, MD
Sub-Investigator
United States South Carolina Charleston 29415 Medical University of South Carolina
Adrian T Parker
parkerad@musc.edu

Raymond D Turner, MD
Principal Investigator

M Imran Chaudry, MD
Sub-Investigator

Aquilla S Turk, DO
Sub-Investigator

Alejandro M Spiotta, MD
Sub-Investigator
United States Tennessee Nashville 37232 Vanderbilt University Medical Center
Chesney S Oravec
chesney.s.oravec@vanderbilt.edu

J Mocco, MD, MS
Principal Investigator

Michael Froehler, MD, PhD
Sub-Investigator
United States Texas Dallas 75390 University of Texas - Southwestern
Kim Dutton-Johnson, RN
kim.dutton@utsouthwestern.edu

Babu Welch, MD
Principal Investigator

G Lee Pride, MD
Sub-Investigator
United States Utah Salt Lake City 84132 University of Utah
Lisa Dubler
lisa.dubler@hsc.utah.edu

Philipp Taussky, MD
Principal Investigator

Edwin A Stevens, MD
Sub-Investigator
Netherlands Nijmegen UMC St Radboud
Inge ter Horst
i.terhorst@crcn.umcn.nl

Joost de Vries, MD, PhD
Principal Investigator

Hieronymus D Boogaarts, MD
Sub-Investigator

Contact

Doug Follett, DVM, DACVA
510-413-2207
E-mail:

NCT ID: NCT01716117

Date Last Changed: January 24, 2014

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