Intracranial Aneurysm
Conditions
Keywords
Next Generation Neuroform Stent System, Wide Neck, Intracranial, Saccular Aneurysms, Cerebral Aneurysms
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.
Interventions
DEVICENext 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.
Sponsors
Stryker Neurovascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stroke or Death | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Percent of Subjects Experiencing One or More Serious Adverse Events (SAEs) Through 12 Months | within 12 months post procedure | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 298 |
| Total | 298 |
Baseline characteristics
| Characteristic | Next Generation Neuroform Stent System |
|---|---|
| Age, Continuous | 60.3 years STANDARD_DEVIATION 11 |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 1 Participants |
| Race/Ethnicity, Customized Asian | 5 Participants |
| Race/Ethnicity, Customized black | 34 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 1 Participants |
| Race/Ethnicity, Customized Other | 4 Participants |
| Race/Ethnicity, Customized white | 253 Participants |
| Sex: Female, Male Female | 227 Participants |
| Sex: Female, Male Male | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 298 |
| other Total, other adverse events | 212 / 298 |
| serious Total, serious adverse events | 90 / 298 |
Outcome results
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.
Time frame: 12 month post index procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Neuroform Atlas Stent System (Anterior) | Aneurysm Occlusion of the Treated Target Lesion on 12 Month Angiography | 135 Participants |
| Neuroform Atlas Stent System (Posterior) | Aneurysm Occlusion of the Treated Target Lesion on 12 Month Angiography | 81 Participants |
Primary
Stroke or Death
Any major ipsilateral stroke or neurological death
Time frame: within 12 months of the index procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Neuroform Atlas Stent System (Anterior) | Stroke or Death | 8 Participants |
| Neuroform Atlas Stent System (Posterior) | Stroke or Death | 5 Participants |
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
Time frame: within 12 months post procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Neuroform Atlas Stent System (Anterior) | The Percent of Subjects Experiencing One or More Serious Adverse Events (SAEs) Through 12 Months | 20 Participants |
| Neuroform Atlas Stent System (Posterior) | The Percent of Subjects Experiencing One or More Serious Adverse Events (SAEs) Through 12 Months | 19 Participants |