Neuroform Atlas IDE Study



Status:Active, not recruiting
Conditions:Cardiology, Neurology
Therapuetic Areas:Cardiology / Vascular Diseases, Neurology
Healthy:No
Age Range:18 - 80
Updated:9/8/2018
Start Date:June 2015
End Date:December 2020

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Safety and Effectiveness of the Treatment of Wide Neck, Intracranial, Saccular Aneurysms With the Next Generation Neuroform Stent System

The primary objective of this study is to demonstrate effectiveness and safety of the
Neuroform Atlas Stent System for use with bare metal embolic coils.

The study is a prospective, multicenter, open-label, single arm trial designed to demonstrate
the potential treatment of wide neck, intracranial, saccular aneurysms with the Next
Generation Neuroform Stent System with any approved embolic coils currently on the market.
The study will evaluate the percent occlusion of the treated target lesion on angiography in
the absence of retreatment, or parent artery stenosis at the target location at 12 months.
Subjects with documented wide neck, intracranial, saccular aneurysms arising from a parent
artery may potentially benefit from stent assisted coiling, provided they meet the other
eligibility criteria.

Inclusion Criteria:

1. Subject is between 18 and 80 years of age

2. Documented wide neck (neck ≥ 4 mm or a dome-to-neck ratio of < 2), intracranial,
saccular aneurysm arising from a parent vessel with a diameter of ≥ 2mm and ≤ 4.5 mm,
which will be treated with bare metal coils

3. Subject or legal representative is willing and able to provide informed consent

4. Subject is willing and able to comply with protocol follow-up requirements

Exclusion Criteria:

1. Known multiple untreated cerebral aneurysms, other than non-target blister aneurysm,
infundibulum, or aneurysm measuring <3mm for each of three dimensions assessed
(height, width, and depth) that will not require treatment during the study period

2. Target lesion is a blister aneurysm, infundibulum, or aneurysm measuring <3mm for each
of three dimensions assessed (height, width, and depth)

3. Target aneurysm that will require an Investigator to intentionally leave a neck
remnant in order to preserve blood flow in a bifurcation or branch

4. Coiling or stenting of a non-target intracranial aneurysm within 30 days prior to
study treatment

5. Target aneurysm is in the anterior circulation proximal to the superior hypophyseal
ICA

6. Acute target aneurysm rupture less than 14 days prior to study treatment

7. Hunt and Hess score ≥ 3 or a premorbid mRS score ≥4

8. An admission platelet count of <50,000, any known coagulopathy, or an International
Normalized Ratio (INR)>3.0 without oral anticoagulation therapy

9. A known absolute contraindication to angiography

10. Evidence of active cancer, terminal illness or any condition which, in the opinion of
the treating physician, would/could prevent subject from completing the study (e.g., a
high risk of embolic stroke, atrial fibrillation, co-morbidities, psychiatric
disorders, substance abuse, major surgery ≤ 30 days pre-procedure, etc.)

11. Known absolute contraindication to the use of required study medications or agents
(e.g., heparin, aspirin, clopidogrel, and radiographic contrast agents, etc.)

12. Female subject who is pregnant or intends to become pregnant during the study

13. Moya-Moya disease, arteriovenous malformation(s), arteriovenous fistula(e),
intracranial tumor(s), or intracranial hematoma(s) (unrelated to target aneurysm)

14. Significant atherosclerotic stenosis, significant vessel tortuosity, vasospasm
refractory to medication, unfavorable aneurysm morphology or vessel anatomy, or some
other condition(s) that, in the opinion of the treating physician, would/could prevent
or interfere with access to the target aneurysm and/or successful deployment of the
Neuroform Atlas™ Stent

15. Previous treatment (e.g., surgery, stenting) in the parent artery that, in the opinion
of the treating physician, would/could prevent or interfere with successful use of the
Neuroform Atlas™ Stent System and/or successful adjunctive deployment of embolic coils

16. Previous stent-assisted coiling of the target aneurysm
We found this trial at
26
sites
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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Worcester, MA
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
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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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Principal Investigator: Adel Malek, MD
Phone: 617-636-7606
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Boston, MA
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Ajith Thomas, MD
Phone: 617-632-0949
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, CA
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
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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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Principal Investigator: Michelle Smith, MD
Phone: 215-662-6462
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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Bridgeton, Missouri 63044
Principal Investigator: Richard Callison, MD
Phone: 314-344-7093
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Buffalo, NY
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Aquilla Turk, MD
Phone: 843-792-7434
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
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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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Gabor Toth, MD
Phone: 216-442-5676
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Cleveland, OH
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Englewood, Colorado 80112
Principal Investigator: David Loy, MD
Phone: 720-493-3403
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Houston, Texas 77030
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6550 Fannin St
Houston, Texas 77030
(713) 790-3311
Principal Investigator: Richard Klucznik, MD
Phone: 713-441-3247
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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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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Lexington, Kentucky 40536
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Marietta, Georgia 30106
Principal Investigator: Ahmad Khaldi, MD
Phone: 470-793-4046
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Memphis, Tennessee 38120
Principal Investigator: Adam Arthur, MD
Phone: 901-522-2542
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Newark, Delaware 19713
Principal Investigator: Sudhakar Satti, MD
Phone: 302-733-4164
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
Principal Investigator: Brian Jankowitz, MD
Phone: 412-605-3959
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Richmond, Virginia 23298
(804) 828-0100
Principal Investigator: John Reavey-Cantwell, MD
Phone: 804-828-9882
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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325 9th Ave
Seattle, Washington 98104
(206) 744-3300
Principal Investigator: Danial Hallam, MD
Phone: 206-744-8018
Harborview Medical Center Harborview Medical Center is the only designated Level 1 adult and pediatric...
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Thousand Oaks, California 91360
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Toledo, OH
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8300 West 38th Avenue
Wheat Ridge, Colorado 80033
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