Neuroform Atlas Stent System Study

Not Applicable

Completed

• Conditions: Intracranial Aneurysm
• Interventions: Device: Next Generation Neuroform Stent System

• Registration Number: NCT02340585
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2015-01-13
• Study First Submitted QC: 2015-01-13
• Study First Posted: 2015-01-16
• Study Start: 2015-06-18
• Results First Submitted: 2021-07-29
• Primary Completion: 2021-12-13
• Study Completion: 2022-09-30
• Status Verified: 2023-03
• Results First Submitted QC: 2023-03-01
• Last Update Submitted: 2023-03-01
• Results First Posted: 2023-03-24
• Last Update Posted: 2023-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 298

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Next Generation Neuroform Stent System	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.

Primary Outcome Measures

Name	Time	Method
Aneurysm Occlusion of the Treated Target Lesion on 12 Month Angiography	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.
Stroke or Death	within 12 months of the index procedure	Any major ipsilateral stroke or neurological death

Secondary Outcome Measures

Name	Time	Method
The Percent of Subjects Experiencing One or More Serious Adverse Events (SAEs) Through 12 Months	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

Trial Locations

Locations (25)

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

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