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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 : Enrolling by invitation
First Posted : January 16, 2015
Last Update Posted : March 8, 2021
Sponsor:
Information provided by (Responsible Party):
Stryker Neurovascular

Tracking Information
First Submitted Date  ICMJE January 13, 2015
First Posted Date  ICMJE January 16, 2015
Last Update Posted Date March 8, 2021
Actual Study Start Date  ICMJE June 2015
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2015)
  • Stroke or Death [ Time Frame: within 12 months of the index procedure ]
  • Complete aneurysm occlusion of the treated target lesion on 12 mnth angiography [ Time Frame: 12 month ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2015)
  • New or worsening major ipsilateral stroke as measured [ Time Frame: within 12 months post procedure ]
  • Device related serious adverse events [ Time Frame: within 12 months post procedure ]
  • Subarachnoid hemorrhage [ Time Frame: within 12 months post procedure ]
  • Aneurysm rupture [ Time Frame: within 12 months post procedure ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neuroform Atlas Stent System Study
Official Title  ICMJE Safety and Effectiveness of the Treatment of Wide Neck, Intracranial, Saccular Aneurysms With the Next Generation Neuroform Stent System
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Intracranial Aneurysm
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Device: Next Generation Neuroform Stent System
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: August 9, 2016)
360
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02340585
Other Study ID Numbers  ICMJE ATLAS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stryker Neurovascular
Study Sponsor  ICMJE Stryker Neurovascular
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Osama Zaidat, MD Mercy Health - St. Vincent Medical Center
Principal Investigator: Brian Jankowitz, MD Cooper University Health Center
PRS Account Stryker Neurovascular
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP