Neuroform Atlas Stent System Study

Completed · Not applicable

Conditions studied: Intracranial Aneurysm

In brief

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.

Key facts

Study ID

NCT02340585

Run by

Stryker Neurovascular

People needed

298

Starts

2015-06-18

Expected to finish

2022-09-30

Last updated by the study team

2023-03-24

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is between 18 and 80 years of age
• 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
• Subject or legal representative is willing and able to provide informed consent
• Subject is willing and able to comply with protocol follow-up requirements

You may not qualify if…

• 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
• Target lesion is a blister aneurysm, infundibulum, or aneurysm measuring <3mm for each of three dimensions assessed (height, width, and depth)
• Target aneurysm that will require an Investigator to intentionally leave a neck remnant in order to preserve blood flow in a bifurcation or branch
• Coiling or stenting of a non-target intracranial aneurysm within 30 days prior to study treatment
• Target aneurysm is in the anterior circulation proximal to the superior hypophyseal ICA
• Acute target aneurysm rupture less than 14 days prior to study treatment
• Hunt and Hess score ≥ 3 or a premorbid mRS score ≥4
• An admission platelet count of <50,000, any known coagulopathy, or an International Normalized Ratio (INR)>3.0 without oral anticoagulation therapy
• A known absolute contraindication to angiography
• 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.)
• Known absolute contraindication to the use of required study medications or agents (e.g., heparin, aspirin, clopidogrel, and radiographic contrast agents, etc.)
• Female subject who is pregnant or intends to become pregnant during the study
• Moya-Moya disease, arteriovenous malformation(s), arteriovenous fistula(e), intracranial tumor(s), or intracranial hematoma(s) (unrelated to target aneurysm)
• 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
• 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
• Previous stent-assisted coiling of the target aneurysm

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Vascular Neurology of Southern California — Thousand Oaks, California, United States
• Radiology Imaging Associates — Englewood, Colorado, United States
• Christiana Care Health Services — Newark, Delaware, United States
• Lyerly Neurosurgery — Jacksonville, Florida, United States
• WellStar Kennestone Hospital — Marietta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Kentucky Research Foundation — Lexington, Kentucky, United States
• The Johns Hopkins University — Baltimore, Maryland, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• University of Massachusetts Medical School — Worcester, Massachusetts, United States
• SSM Health DePaul Hospital — Bridgeton, Missouri, United States
• SUNY University at Buffalo Neurosurgery/Gates Vascular Institute — Buffalo, New York, United States
• The Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Mercy Health - St. Vincent Medical Center — Toledo, Ohio, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Methodist Healthcare - Memphis Hospitals — Memphis, Tennessee, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Baylor St. Luke's Medical Center — Houston, Texas, United States
• Houston Methodist Hospital — Houston, Texas, United States
• Virginia Commonwealth University — Richmond, Virginia, United States
• Harborview Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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