Clinical Trial Details

NCT ID: NCT01716117
Date Last Changed: November 16, 2015

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 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).

To Learn more

Recruitment Details

Gender
Both Male and Female
Age
19 to 80 Years
Overall Status
Recruiting
Lead Sponsor
Stryker Neurovascular
Duration
50 Months
Facility Type
N/A
Compensation

Eligibility

Both Male and Female ages 19 Years to 80 Years

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)

Site Locations (27)

Country State City Zip Facility and Contact
United States California Irvine 92697 University of California
Katrina Samson
949-824-3485
samsonk@uci.edu

Li-Mei Lin, MD
Principal Investigator

Shuichi Suzuki, MD
Sub-Investigator

Kiarash Golshani, MD
Sub-Investigator
United States California Santa Barbara 93105 Santa Barbara Cottage Hospital
Samantha Yim
805-569-7461
syim@sbch.org

Alois Zauner, MD
Principal Investigator

Samuel Hou, MD
Sub-Investigator

Robert Taylor, MD
Sub-Investigator
United States California Stanford 94305 Stanford Hospital
Kara Richardson
650-736-6171
kjr9@stanford.edu

Robert Dodd, MD
Principal Investigator

Huy Do, MD
Sub-Investigator
United States Florida Gainesville 32611 University of Florida
Jessica Smith
352-273-7773
Jessica.Smith@neurosurgery.ufl.edu

Brian L Hoh, MD
Principal Investigator
United States Florida Jacksonville 32207 Lyerly Neurosurgery/Baptist Health System
Nancy Ebreo
904-398-0125 ext. 1434
nancy.ebreo@bmcjax.com

Ricardo Hanel, MD
Principal Investigator

Eric Sauvageau, MD
Sub-Investigator
United States Florida Jacksonville 32224 Mayo Clinic - Florida
Sabrina Huskic
904-953-3062
huskic.sabrina@mayo.edu

Rabih G Tawk, MD
Principal Investigator

David A Miller, MD
Sub-Investigator
United States Florida Miami 33176 Baptist Hospital of Miami
Sarah Orendorff-Alegre
786-596-5336
SarahO@baptisthealth.net

Italo Linfante, MD
Principal Investigator

Guilherme Dabus, MD
Sub-Investigator
United States Florida Tampa 33606 Tampa General Hospital
Marlene Martin
813-844-5012
marlenecmartin@tgh.org

Maxim Mokin, MD
Principal Investigator
United States Illinois Chicago 60612 Rush University Medical Center
Christy M Anton
312-942-1489
Christy_Anton@rush.edu

Demetrius K Lopes, MD
Principal Investigator

Michael Chen, MD
Sub-Investigator
United States Kansas Kansas City 66160 The University of Kansas Medical Center
Jason Gorup
913-588-1035
jgorup@kumc.edu

Koji Ebersole, MD
Principal Investigator

Alan Reeves, MD
Sub-Investigator

Ernest J Madarang, MD
Sub-Investigator
United States Maryland Baltimore 21287 Johns Hopkins University
Barbara Michniewicz, RN
410-955-2438
bwawrys1@jhmi.edu

Geoffrey P Colby, MD, PhD
Principal Investigator
United States Massachusetts Worcester 01655 University of Massachusetts Medical School
Mary Howk
774-441-8442
mary.howk@umassmed.edu

Ajit Puri, MD
Principal Investigator

Francesco Massari, MD, PhD
Sub-Investigator
United States Minnesota Rochester 55902 Mayo Clinic - Minnesota
Beth Connelly, CCRP
507-538-3928
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 Buffalo 14203 University at Buffalo
Linda Bookhagen
716-888-4809
lbookhagen@ubns.com

Adnan Siddiqui, MD
Principal Investigator

Kenneth Snyder, MD
Sub-Investigator

Elad Levy, MD
Sub-Investigator
United States New York New York 10032 Columbia University
Virginia Cox, RN
212-305-3349
vc94@mail.cumc.columbia.edu

Philip M Meyers, MD
Principal Investigator

Sean D Lavine, MD
Sub-Investigator
United States Ohio Cleveland 44195 Cleveland Clinic
Amy Richmond
216-444-9524
RICHMOA@ccf.org

Mark Bain, MD
Principal Investigator

Gabor Toth, MD
Sub-Investigator
United States Oregon Portland 97239 Oregon Health and Science University
Brittney Brown
503-494-7222
browbr@ohsu.edu

Aclan Dogan, MD
Principal Investigator

Ryan Priest, MD
Sub-Investigator

Hormozd Bozorgchami, MD
Sub-Investigator

Bryan Petersen, MD
Sub-Investigator

Wayne Clark, MD
Sub-Investigator

Gary Nesbit, MD
Sub-Investigator

Kory Herrick, MD
Sub-Investigator
United States Pennsylvania Philadelphia 19107 Thomas Jefferson University
Michelle Orlando
215-503-5646
Michelle.Orlando@jefferson.edu

Pascal Jabbour, MD
Principal Investigator

Stavropoula Tjoumakaris, MD
Sub-Investigator
United States South Carolina Charleston 29425 Medical University of South Carolina
Emily Young
843-792-6210
youngem@musc.edu

Raymond D Turner, MD
Principal Investigator

Mohammad I Chaudry, MD
Sub-Investigator

Aquilla S Turk, DO
Sub-Investigator

Alejandro M Spiotta, MD
Sub-Investigator
United States Tennessee Knoxville 37916 Fort Sanders Medical Center
Carla Staruk
865-541-2925
cjackso3@CovHlth.com

Keith Woodward, MD
Principal Investigator
United States Tennessee Nashville 37232 Vanderbilt University Medical Center
Matthew Warrick
615-936-6620
matthew.m.warrick@vanderbilt.edu

Michael Froehler, MD, PhD
Principal Investigator
United States Texas Dallas 75390 University of Texas - Southwestern
Kim Dutton-Johnson, RN
214 645-7046
kim.dutton@utsouthwestern.edu

Babu Welch, MD
Principal Investigator

G Lee Pride, MD
Sub-Investigator
United States Texas Houston 77030 Baylor College of Medicine
SreeVidya Coimbatore
832-355-7019
csreevidya@stlukeshealth.org

Peter T Kan, MD
Principal Investigator

Hesham Morsi, MD
Sub-Investigator

Edward Duckworth, MD
Sub-Investigator
United States Utah Salt Lake City 84132 University of Utah
Salman Yakub
801-213-3765
salman.yakub@hsc.utah.edu

Philipp Taussky, MD
Principal Investigator

Edwin A Stevens, MD
Sub-Investigator
United States Virginia Charlottesville 22908 University of Virginia
Julia Krupa
434-924-4023
JKK8D@hscmail.mcc.virginia.edu

Avery Evans, MD
Principal Investigator

Kenneth Liu, MD
Sub-Investigator

Webster Crowley, MD
Sub-Investigator
United States Wisconsin Milwaukee 53226 The Medical College of Wisconsin
Ling Zhong, PhD
414-805-5415
lzhong@mcw.edu

Brian-Fred Fitzsimmons, MD
Principal Investigator

John Lynch, MD
Sub-Investigator
Netherlands Nijmegen UMC St Radboud
Inge ter Horst
(024) 36 68335
i.terhorst@crcn.umcn.nl

Joost de Vries, MD, PhD
Principal Investigator

Hieronymus D Boogaarts, MD
Sub-Investigator

Contact

Diana Espinoza
510-413-2158
E-mail:

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