Neuroform Atlas Stent System Study

NCT ID: NCT02340585

Last Updated: 2023-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 298 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-18
• Study Completion Date: 2022-09-30

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.

Conditions

Intracranial Aneurysm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Next Generation Neuroform Stent System

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stryker Neurovascular

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Osama Zaidat, MD

Role: PRINCIPAL_INVESTIGATOR

Mercy Health - St. Vincent Medical Center

Brian Jankowitz, MD

Role: PRINCIPAL_INVESTIGATOR

Cooper University Health Center

Locations

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

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

University of Massachusetts Medical School

Worcester, Massachusetts, United States

SSM Health DePaul Hospital

Bridgeton, Missouri, United States

SUNY University at Buffalo Neurosurgery/Gates Vascular Institute

Buffalo, New York, United States

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Mercy Health - St. Vincent Medical Center

Toledo, Ohio, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Methodist Healthcare - Memphis Hospitals

Memphis, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Baylor St. Luke's Medical Center

Houston, Texas, United States

Houston Methodist Hospital

Houston, Texas, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Harborview Medical Center

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37940387 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33722961 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32568654 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ATLAS

Identifier Type: -

Identifier Source: org_study_id