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Neuroform Atlas IDE Study

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ClinicalTrials.gov Identifier: NCT02340585
Recruitment Status : Active, not recruiting
First Posted : January 16, 2015
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
Stryker Neurovascular

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
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
Study Start Date : June 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

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.




Primary Outcome Measures :
  1. Stroke or Death [ Time Frame: within 12 months of the index procedure ]
  2. Complete aneurysm occlusion of the treated target lesion on 12 mnth angiography [ Time Frame: 12 month ]

Secondary Outcome Measures :
  1. New or worsening major ipsilateral stroke as measured [ Time Frame: within 12 months post procedure ]
  2. Device related serious adverse events [ Time Frame: within 12 months post procedure ]
  3. Subarachnoid hemorrhage [ Time Frame: within 12 months post procedure ]
  4. Aneurysm rupture [ Time Frame: within 12 months post procedure ]


Information from the National Library of Medicine

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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

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


  Show 26 Study Locations
Sponsors and Collaborators
Stryker Neurovascular
Investigators
Principal Investigator: Osama Zaidat, MD Mercy Health - St. Vincent Medical Center
Principal Investigator: Brian Jankowitz, MD University of Pittsburgh

Responsible Party: Stryker Neurovascular
ClinicalTrials.gov Identifier: NCT02340585     History of Changes
Other Study ID Numbers: ATLAS Study
First Posted: January 16, 2015    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018

Keywords provided by Stryker Neurovascular:
Next Generation Neuroform Stent System
Wide Neck, Intracranial, Saccular Aneurysms
Cerebral Aneurysms

Additional relevant MeSH terms:
Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases