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Neuroform Atlas Stent System Study (ATLAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02340585
Recruitment Status : Completed
First Posted : January 16, 2015
Results First Posted : March 24, 2023
Last Update Posted : March 24, 2023
Sponsor:
Information provided by (Responsible Party):
Stryker Neurovascular

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Intracranial Aneurysm Device: Next Generation Neuroform Stent System Not Applicable

Detailed Description:

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.

Data collected through the 12-month follow-up visit are intended to support Premarket Approval (PMA) application to the Food and Drug Administration (FDA). Long-term follow-up data collected through 3 years postoperative are intended to support post-approval study (PAS) requirements.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 298 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Effectiveness of the Treatment of Wide Neck, Intracranial, Saccular Aneurysms With the Next Generation Neuroform Stent System
Actual Study Start Date : June 18, 2015
Actual Primary Completion Date : December 13, 2021
Actual Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Arms and Interventions
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Arm Intervention/treatment
Experimental: Next Generation Neuroform Stent System
The Next Generation Stent System is a self-expanding, open cell, nitinol stent designed to provide support of the coil mass within the aneurysm and minimize stent deflection.
 Device: Next Generation Neuroform Stent System
The Next Generation Neuroform Stent System is pre-loaded on a stent delivery wire and protected by a transfer sheath. An accessory pouch containing an optional stabilizer may be attached to the proximal end of the stent delivery wire to facilitate handling and stabilization.


Outcome Measures
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Primary Outcome Measures :
  1. Stroke or Death [ Time Frame: within 12 months of the index procedure ]
    Any major ipsilateral stroke or neurological death

  2. Aneurysm Occlusion of the Treated Target Lesion on 12 Month Angiography [ Time Frame: 12 month post index procedure ]
    Complete aneurysm occlusion (100% occlusion - Raymond Class 1) of the treated target lesion on 12 month angiography, in the absence of retreatment, or parent artery stenosis (> 50%) at the target location.


Secondary Outcome Measures :
  1. The Percent of Subjects Experiencing One or More Serious Adverse Events (SAEs) Through 12 Months [ Time Frame: within 12 months post procedure ]

    The percent of subjects experiencing one or more serious adverse events (SAEs) through 12 months including

    • New or worsening major ipsilateral stroke as measured by the National Institute of Health Stroke Scale (NIHSS)
    • Device-related SAEs
    • Subarachnoid hemorrhage (SAH)
    • Aneurysm rupture


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02340585


Locations
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Sponsors and Collaborators
Stryker Neurovascular
Investigators
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Principal Investigator: Osama Zaidat, MD Mercy Health - St. Vincent Medical Center
Principal Investigator: Brian Jankowitz, MD Cooper University Health Center
  Study Documents (Full-Text)

Documents provided by Stryker Neurovascular:
Study Protocol and Statistical Analysis Plan  [PDF] November 19, 2019

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Stryker Neurovascular
ClinicalTrials.gov Identifier: NCT02340585    
Other Study ID Numbers: ATLAS
First Posted: January 16, 2015    Key Record Dates
Results First Posted: March 24, 2023
Last Update Posted: March 24, 2023
Last Verified: March 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Stryker Neurovascular:
Next Generation Neuroform Stent System
Wide Neck, Intracranial, Saccular Aneurysms
Cerebral Aneurysms
Additional relevant MeSH terms:
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Intracranial Aneurysm
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
 Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases