Clinical Trial Details

NCT ID: NCT01716117
Date Last Changed: November 18, 2014


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)


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

Recruitment Details

Both Male and Female
19 to 80 Years
Overall Status
Lead Sponsor
Stryker Neurovascular
26 Months
Facility Type


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

  • Known allergy to nickel, chromium cobalt, tungsten or platinum.

  • 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 (22)

Country State City Zip Facility and Contact
United States California Stanford 94305 Stanford Hospital
Kara Richardson

Robert Dodd, MD
Principal Investigator

Huy Do, MD
United States Florida Gainesville 32605 University of Florida
Nicolle Wilson

Spiros Blackburn, MD
Principal Investigator

Brian L Hoh, MD
United States Florida Jacksonville 32207 Lyerly Neurosurgery/Baptist Health System
Nancy Ebreo

Ricardo Hanel, MD
Principal Investigator

Eric Sauvageau, MD
United States Florida Jacksonville 32224 Mayo Clinic - Florida
Jessie Sperrazza

Rabih G Tawk, MD
Principal Investigator

David A Miller, MD
United States Florida Miami 33176 Baptist Hospital of Miami
Sarah Orendorff-Alegre

Italo Linfante, MD
Principal Investigator

Guilherme Dabus, MD
United States Florida Tampa 33606 Tampa General Hospital
Haydy Rojas

Peter T Kan, MD
Principal Investigator

Zinovy M Katz, MD
United States Illinois Chicago 60612 Rush University Medical Center
Christy M Anton

Demetrius K Lopes, MD
Principal Investigator

Michael Chen, MD

Roham Moftakhar, MD
United States Maryland Baltimore 21287 Johns Hopkins University
Barbara Michniewicz, RN

Alexander L Coon, MD
Principal Investigator

Geoffrey P Colby, MD, PhD

Li-mei Lin, MD
United States Massachusetts Worcester 01655 University of Massachusetts Medical School
Mary Howk

Ajith Puri, MD
Principal Investigator
United States Minnesota Rochester 55902 Mayo Clinic - Minnesota
Beth Connelly, CCRP

Guiseppe Lanzino, MD
Principal Investigator

Harry J Cloft, MD, PhD

David F Kallmes, MD
United States New York Buffalo 14203 University of Buffalo
Shelby Hall

Adnan Siddiqui, MD
Principal Investigator
United States New York New York 10032 Columbia University
Virginia Cox, RN

Philip M Meyers, MD
Principal Investigator

Daniel H Sahlein, MD

Sean D Lavine, MD
United States Ohio Cleveland 44195 Cleveland Clinic
Amy Richmond

Mark Bain, MD
Principal Investigator

Gabor Toth, MD
United States Oregon Portland 97239 Oregon Health and Science University
Sarah Jamieson

Stanley Barnwell, MD, PhD
Principal Investigator

Aclan Dogan, MD
United States Pennsylvania Philadelphia 19107 Thomas Jefferson University
Pamela Tremarki

Pascal Jabbour, MD
Principal Investigator

Stavropoula Tjoumakaris, MD
United States South Carolina Charleston 29415 Medical University of South Carolina
Adrian T Parker

Raymond D Turner, MD
Principal Investigator

M Imran Chaudry, MD

Aquilla S Turk, DO

Alejandro M Spiotta, MD
United States Tennessee Knoxville 37916 Fort Sanders Medical Center
Carla Staruk

Keith Woodward, MD
Principal Investigator
United States Tennessee Nashville 37232 Vanderbilt University Medical Center
Chesney S Oravec

J Mocco, MD, MS
Principal Investigator

Michael Froehler, MD, PhD
United States Texas Dallas 75390 University of Texas - Southwestern
Kim Dutton-Johnson, RN

Babu Welch, MD
Principal Investigator

G Lee Pride, MD
United States Utah Salt Lake City 84132 University of Utah
Lisa Dubler

Philipp Taussky, MD
Principal Investigator

Edwin A Stevens, MD
United States Virginia Charlottesville 22908 University of Virginia
Thomas Tandy

Kenneth Liu, MD
Principal Investigator

Webster Crowley, MD
Netherlands Nijmegen UMC St Radboud
Inge ter Horst

Joost de Vries, MD, PhD
Principal Investigator

Hieronymus D Boogaarts, MD


Diana Espinoza

DISCLAIMER: CenterWatch does not conduct clinical research. CenterWatch is a publishing company that posts clinical trials information on behalf of sponsor companies, contract research organizations, clinical research sites and other interested parties. This information is designed to help patients find clinical trials of interest and contact the research centers conducting the trials.