Clinical trial NCT02340585: Neuroform Atlas Stent System Study
Official title: Safety and Effectiveness of the Treatment of Wide Neck, Intracranial, Saccular Aneurysms With the Next Generation Neuroform Stent System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intracranial Aneurysm
Keywords: Next Generation Neuroform Stent System
Wide Neck, Intracranial, Saccular Aneurysms
Cerebral Aneurysms
Lead sponsor: Stryker Neurovascular
Sponsor class: INDUSTRY
First posted: 2015-01-16
Enrollment: 298
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Stroke or Death
timeFrame: within 12 months of the index procedure
measure: Aneurysm Occlusion of the Treated Target Lesion on 12 Month Angiography
timeFrame: 12 month post index procedure
Secondary outcomes:
measure: The Percent of Subjects Experiencing One or More Serious Adverse Events (SAEs) Through 12 Months
timeFrame: within 12 months post procedure
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Thousand Oaks
country: United States
facility: Vascular Neurology of Southern California
state: California
city: Englewood
country: United States
facility: Radiology Imaging Associates
state: Colorado
city: Newark
country: United States
facility: Christiana Care Health Services
state: Delaware
city: Jacksonville
country: United States
facility: Lyerly Neurosurgery
state: Florida
city: Marietta
country: United States
facility: WellStar Kennestone Hospital
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Lexington
country: United States
facility: University of Kentucky Research Foundation
state: Kentucky
city: Baltimore
country: United States
facility: The Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
city: Bridgeton
country: United States
facility: SSM Health DePaul Hospital
state: Missouri
city: Buffalo
country: United States
facility: SUNY University at Buffalo Neurosurgery/Gates Vascular Institute
state: New York
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Toledo
country: United States
facility: Mercy Health - St. Vincent Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Memphis
country: United States
facility: Methodist Healthcare - Memphis Hospitals
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: Baylor St. Luke's Medical Center
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
Study officials:
affiliation: Mercy Health - St. Vincent Medical Center
name: Osama Zaidat, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cooper University Health Center
name: Brian Jankowitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jankowitz BT, Jadhav AP, Gross B, Jovin TG, Alhajeri AA, Fraser JF, Hanel RA, Sauvageau E, Aghaebrahim A, Frei D, Bellon R, Loy D, Puri AS, Malek AM, Thomas A, Toth G, Lopes DK, Crowley RW, Arthur AS, Reavey-Cantwell J, Lin E, Siddiqui AH, Alexander MJ, Khaldi A, Colby GP, Caplan JM, Satti SR, Turk AS, Spiotta AM, Klucznik R, Hallam DK, Kung D, Froehler MT, Callison RC, Kan P, Hetts SW, Zaidat OO. Pivotal trial of the Neuroform Atlas stent for treatment of posterior circulation aneurysms: one-year outcomes. J Neurointerv Surg. 2022 Feb;14(2):143-148. doi: 10.1136/neurintsurg-2020-017115. Epub 2021 Mar 15.
citation: Zaidat OO, Hanel RA, Sauvageau EA, Aghaebrahim A, Lin E, Jadhav AP, Jovin TG, Khaldi A, Gupta RG, Johnson A, Frei D, Loy D, Malek A, Toth G, Siddiqui A, Reavey-Cantwell J, Thomas A, Hetts SW, Jankowitz BT; ATLAS Investigators. Pivotal Trial of the Neuroform Atlas Stent for Treatment of Anterior Circulation Aneurysms: One-Year Outcomes. Stroke. 2020 Jul;51(7):2087-2094. doi: 10.1161/STROKEAHA.119.028418. Epub 2020 Jun 17.