Neuroform Atlas Stent System Study

Intracranial Aneurysm Clinical Trial

— ATLAS  

Official title:

Safety and Effectiveness of the Treatment of Wide Neck, Intracranial, Saccular Aneurysms With the Next Generation Neuroform Stent System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02340585
• Other study ID #: ATLAS
• Status: Completed
• Phase: N/A
• Start date: June 18, 2015
• Est. completion date: September 30, 2022

Study information

• Verified date: March 2023
• Source: Stryker Neurovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 298
• Est. completion date: September 30, 2022
• Est. primary completion date: December 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Neurovascular

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stroke or Death	Any major ipsilateral stroke or neurological death	within 12 months of the index procedure
Primary	Aneurysm Occlusion of the Treated Target Lesion on 12 Month Angiography	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.	12 month post index procedure
Secondary	The Percent of Subjects Experiencing One or More Serious Adverse Events (SAEs) Through 12 Months	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	within 12 months post procedure