Neuroform Atlas Stent System Study

NCT02340585 | Completed Results DMC FDA Device

• 1 other identifier: ATLAS
• Study Type: interventional
• Target: 298
• Locations: 1 country
• Sites: 25

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.

Conditions

Intracranial Aneurysm

Keywords

Next Generation Neuroform Stent System; Wide Neck, Intracranial, Saccular Aneurysms; Cerebral Aneurysms

Outcome Measures

Primary Outcomes (2)

• Stroke or Death

  Any major ipsilateral stroke or neurological death

  within 12 months of the index procedure

• 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 Outcomes (1)

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

  within 12 months post procedure

Study Arms (1)

Next Generation Neuroform Stent System

EXPERIMENTAL

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

Interventions

Next Generation Neuroform Stent System DEVICE

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.

Next Generation Neuroform Stent System

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is between 18 and 80 years of age
• 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
• Subject or legal representative is willing and able to provide informed consent
• Subject is willing and able to comply with protocol follow-up requirements

You may not qualify if:

• 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
• Target lesion is a blister aneurysm, infundibulum, or aneurysm measuring \<3mm for each of three dimensions assessed (height, width, and depth)
• Target aneurysm that will require an Investigator to intentionally leave a neck remnant in order to preserve blood flow in a bifurcation or branch
• Coiling or stenting of a non-target intracranial aneurysm within 30 days prior to study treatment
• Target aneurysm is in the anterior circulation proximal to the superior hypophyseal ICA
• Acute target aneurysm rupture less than 14 days prior to study treatment
• Hunt and Hess score ≥ 3 or a premorbid mRS score ≥4
• An admission platelet count of \<50,000, any known coagulopathy, or an International Normalized Ratio (INR)\>3.0 without oral anticoagulation therapy
• A known absolute contraindication to angiography
• 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.)
• Known absolute contraindication to the use of required study medications or agents (e.g., heparin, aspirin, clopidogrel, and radiographic contrast agents, etc.)
• Female subject who is pregnant or intends to become pregnant during the study
• Moya-Moya disease, arteriovenous malformation(s), arteriovenous fistula(e), intracranial tumor(s), or intracranial hematoma(s) (unrelated to target aneurysm)
• 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
• 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

Sponsors & Collaborators

• Stryker Neurovascular: lead

Study Sites (25)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Vascular Neurology of Southern California

Thousand Oaks, California, 91360, United States

Location

Radiology Imaging Associates

Englewood, Colorado, 80113, United States

Location

Christiana Care Health Services

Newark, Delaware, 19718, United States

Location

Lyerly Neurosurgery

Jacksonville, Florida, 32207, United States

Location

WellStar Kennestone Hospital

Marietta, Georgia, 30060, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Kentucky Research Foundation

Lexington, Kentucky, 40506, United States

Location

The Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

SSM Health DePaul Hospital

Bridgeton, Missouri, 63044, United States

Location

SUNY University at Buffalo Neurosurgery/Gates Vascular Institute

Buffalo, New York, 14203, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Mercy Health - St. Vincent Medical Center

Toledo, Ohio, 43608, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15219, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29403, United States

Location

Methodist Healthcare - Memphis Hospitals

Memphis, Tennessee, 38104, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37240, United States

Location

Baylor St. Luke's Medical Center

Houston, Texas, 77030, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Related Publications (3)

• Hanel RA, Cortez GM, Jankowitz BT, Sauvageau E, Aghaebrahim A, Lin E, Jadhav AP, Gross B, Khaldi A, Gupta R, Frei D, Loy D, Price LL, Hetts SW, Zaidat OO; ATLAS Investigators. Anterior circulation location-specific results for stent-assisted coiling - carotid versus distal aneurysms: 1-year outcomes from the Neuroform Atlas Stent Pivotal Trial. J Neurointerv Surg. 2024 Oct 14;16(11):1125-1130. doi: 10.1136/jnis-2023-020591.

  PMID: 37940387 DERIVED

• 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.

  PMID: 33722961 DERIVED

• 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.

  PMID: 32568654 DERIVED

MeSH Terms

Conditions

Intracranial Aneurysm; Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Stacy Phung
• Organization: Stryker

stacy.phung@stryker.com

678 469 2428

Study Officials

• Osama Zaidat, MD

  Mercy Health - St. Vincent Medical Center

  PRINCIPAL INVESTIGATOR

• Brian Jankowitz, MD

  Cooper University Health Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2015
• First Posted: January 16, 2015
• Study Start: June 18, 2015
• Primary Completion: December 13, 2021
• Study Completion: September 30, 2022
• Last Updated: March 24, 2023
• Results First Posted: March 24, 2023

Record last verified: 2023-03

Locations

US (25)