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



Status:Active, not recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:19 - 80
Updated:5/20/2018
Start Date:October 25, 2012
End Date:December 21, 2020

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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 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).

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.

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)
We found this trial at
26
sites
3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Principal Investigator: Geoffrey P Colby, MD, PhD
Phone: 410-955-2438
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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Baltimore, MD
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Mark Bain, MD
Phone: 216-444-9524
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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Gainesville, Florida 32610
(352) 392-3261
Principal Investigator: Brian L Hoh, MD
Phone: 352-273-7773
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Gainesville, FL
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Principal Investigator: Peter T Kan, MD
Phone: 832-355-7019
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Houston, TX
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Michael Froehler, MD, PhD
Phone: 615-936-6620
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Nashville, TN
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116th St and Broadway
New York, New York 10027
(212) 854-1754
Principal Investigator: Philip M Meyers, MD
Phone: 212-305-3349
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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New York, NY
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Aclan Dogan, MD
Phone: 503-494-7222
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Philipp Taussky, MD
Phone: 801-213-3765
University of Utah Research is a major component in the life of the U benefiting...
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Salt Lake City, UT
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1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
Principal Investigator: Maxim Mokin, MD
Phone: 813-844-5012
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
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Tampa, FL
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Buffalo, New York 14215
Principal Investigator: Adnan Siddiqui, MD
Phone: 716-888-4809
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Buffalo, NY
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Raymond D Turner, MD
Phone: 843-792-6210
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: Avery Evans, MD
Phone: 434-924-4023
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Demetrius K Lopes, MD
Phone: 312-942-1489
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chicago, IL
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Dallas, Texas 75390
Principal Investigator: Babu Welch, MD
Phone: 214 645-7046
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Dallas, TX
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Irvine, California 92697
Principal Investigator: Li-Mei Lin, MD
Phone: 949-824-3485
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Irvine, CA
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Jacksonville, Florida 32207
Principal Investigator: Ricardo Hanel, MD
Phone: 904-398-0125
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Jacksonville, FL
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4500 San Pablo Rd S
Jacksonville, Florida 32224
(904) 953-2000
Principal Investigator: Rabih G Tawk, MD
Phone: 904-953-3062
Mayo Clinic Florida Thousands of people come to Mayo Clinic in Jacksonville, Fla., annually for...
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Jacksonville, FL
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
Principal Investigator: Koji Ebersole, MD
Phone: 913-588-1035
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Knoxville, Tennessee 37916
Principal Investigator: Keith Woodward, MD
Phone: 865-541-2925
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8900 N Kendall Dr
Miami, Florida 33176
(786) 596-1960
Principal Investigator: Italo Linfante, MD
Phone: 786-596-5336
Baptist Hospital of Miami Since 1960, Baptist Hospital of Miami has been one of the...
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Miami, FL
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Principal Investigator: Brian-Fred Fitzsimmons, MD
Phone: 414-805-5415
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Milwaukee, WI
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Nijmegen,
Principal Investigator: Joost de Vries, MD, PhD
Phone: (024) 36 68335
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: Pascal Jabbour, MD
Phone: 215-503-5646
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Philadelphia, PA
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Rochester, Minnesota 55905
Principal Investigator: Guiseppe Lanzino, MD
Phone: 507-538-3928
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Rochester, MN
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Santa Barbara, California 93105
Principal Investigator: Alois Zauner, MD
Phone: 805-569-7461
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55 N Lake Ave
Worcester, Massachusetts 01655
(508) 856-8989
Principal Investigator: Ajit Puri, MD
Phone: 774-441-8442
Univ of Massachusetts Med School As the commonwealth's only public medical school, we take seriously...
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