Intracranial AneurysmATLASNCT02340585
Neuroform Atlas Stent System Study
A study testing Next Generation Neuroform Stent System in people with Intracranial Aneurysm, run by Stryker Neurovascular at 25 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- Next Generation Neuroform Stent System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 298 participants
- Where
- 25 sitesUnited States
- Study dates
- 18 Jun 2015to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
- Previous stent-assisted coiling of the target aneurysm
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
The Johns Hopkins University
Baltimore, Maryland, 21205
Tufts Medical Center
Boston, Massachusetts, 02111
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
SSM Health DePaul Hospital
Bridgeton, Missouri, 63044
SUNY University at Buffalo Neurosurgery/Gates Vascular Institute
Buffalo, New York, 14203
Medical University of South Carolina
Charleston, South Carolina, 29403
Rush University Medical Center
Chicago, Illinois, 60612
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Radiology Imaging Associates
Englewood, Colorado, 80113
Baylor St. Luke's Medical Center
Houston, Texas, 77030
Houston Methodist Hospital
Houston, Texas, 77030
Lyerly Neurosurgery
Jacksonville, Florida, 32207
University of Kentucky Research Foundation
Lexington, Kentucky, 40506
Cedars-Sinai Medical Center
Los Angeles, California, 90048
WellStar Kennestone Hospital
Marietta, Georgia, 30060
Methodist Healthcare - Memphis Hospitals
Memphis, Tennessee, 38104
Vanderbilt University Medical Center
Nashville, Tennessee, 37240
Christiana Care Health Services
Newark, Delaware, 19718
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15219
Virginia Commonwealth University
Richmond, Virginia, 23298
Harborview Medical Center
Seattle, Washington, 98104
Vascular Neurology of Southern California
Thousand Oaks, California, 91360
Mercy Health - St. Vincent Medical Center
Toledo, Ohio, 43608
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
About this study
Official title: Safety and Effectiveness of the Treatment of Wide Neck, Intracranial, Saccular Aneurysms With the Next Generation Neuroform Stent System
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.
Read the 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
- Being tested
- Next Generation Neuroform Stent System
- Keywords
- Next Generation Neuroform Stent System, Wide Neck, Intracranial, Saccular Aneurysms, Cerebral Aneurysms
- Medical subject headings
- Intracranial Aneurysm, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Next Generation Neuroform Stent SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Next Generation Neuroform Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke or Death
Any major ipsilateral stroke or neurological death
Measured: 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.
Measured: 12 month post index procedure
Secondary outcomes (1)
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
Measured: within 12 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2015 (estimated)
- Study start18 Jun 2015
- Primary completion13 Dec 2021
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 298 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Neurovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Osama Zaidat, MD, Principal investigator, Mercy Health - St. Vincent Medical CenterBrian Jankowitz, MD, Principal investigator, Cooper University Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02340585
- Sponsor's protocol ID
- ATLAS
- Acronym
- ATLAS
- Status last verified
- Mar 2023
- First submitted
- 13 Jan 2015
- Last updated
- 24 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 37940387Jankowitz 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.
PubMed 33722961Zaidat 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.
PubMed 32568654
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of the Treatment of Wide Neck, Intracranial, Saccular Aneurysms With the Next Generation Neuroform Stent System
- ClinicalTrials.gov ID
- NCT02340585
- Acronym / sponsor ID
- ATLAS / ATLAS
- Conditions
- Intracranial Aneurysm
- Keywords
- Next Generation Neuroform Stent System, Wide Neck, Intracranial, Saccular Aneurysms, Cerebral Aneurysms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 298 participants (actual)
- Lead sponsor
- Stryker NeurovascularIndustry (pharma, biotech, devices)
- Study start
- 18 Jun 2015 (actual)
- Primary completion
- 13 Dec 2021 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 16 Jan 2015 (estimated)
- Results
- Posted 24 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Next Generation Neuroform Stent System | Experimental | Device: Next Generation Neuroform Stent SystemThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Next Generation Neuroform Stent SystemThe 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. | Device | Next Generation Neuroform Stent System |
Primary outcome
Stroke or Death
Time frame: within 12 months of the index procedure
Any major ipsilateral stroke or neurological death
Aneurysm Occlusion of the Treated Target Lesion on 12 Month Angiography
Time frame: 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.
1 secondary outcome
The Percent of Subjects Experiencing One or More Serious Adverse Events (SAEs) Through 12 Months
Time frame: within 12 months post procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37940387Hanel 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.
- Derived from this study: PubMed 33722961Jankowitz 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.
- Derived from this study: PubMed 32568654Zaidat 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Osama Zaidat, MD principal investigator
Mercy Health - St. Vincent Medical Center
Brian Jankowitz, MD principal investigator
Cooper University Health Center
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Next Generation Neuroform Stent System in people with Intracranial Aneurysm, run by Stryker Neurovascular at 25 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke or Death (time frame: within 12 months of the index procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02340585, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.