Aneurysm, Intracranial
Conditions
Brief summary
A multi-center, prospective, single-arm, non-randomized, post-market, observational study. The primary objective of this study is to evaluate the long-term safety and efficacy of the Surpass Streamline Flow Diverter System (FDS) in the treatment of unruptured large and giant (≥ 10 mm) saccular wide-neck (neck width ≥ 4 mm) or fusiform intracranial aneurysms in the internal carotid artery from the petrous segment to the terminus arising from a parent vessel with a diameter ≥ 2.5 mm to ≤ 5.3 mm.
Detailed description
The Surpass Streamline FDS is indicated for use in the endovascular treatment of adults (age 18 years or older) with unruptured large (≥ 10 mm) saccular, wide-neck (neck width ≥ 4 mm or dome/neck ratio \< 2 mm) or fusiform intracranial aneurysms in the internal carotid artery from the petrous segment to the terminus arising from a parent vessel with a diameter ≥ 2.5 mm to ≤ 5.3 mm.
Interventions
DEVICESurpass Streamline Flow Diverter System
The Surpass Streamline FDS is indicated for use in the endovascular treatment of adults (age 18 years or older) with unruptured large (≥ 10 mm) saccular, wide-neck (neck width ≥ 4 mm or dome/neck ratio \< 2 mm) or fusiform intracranial aneurysms in the internal carotid artery from the petrous segment to the terminus arising from a parent vessel with a diameter ≥ 2.5 mm to ≤ 5.3 mm.
Sponsors
Stryker (Beijing) Healthcare Products Co., Ltd
Stryker Neurovascular
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1\. Subject age ≥ 18 and ≤ 80 years 2. Subject or legal authorized representative is willing and able to give informed consent 3. Subject has a single targeted intracranial aneurysm that: 1. Is located in the internal carotid artery (ICA) distribution from petrous segment up to the terminus 2. Is able to be crossed with a standard 0.014 guide wire 3. Has unruptured saccular wide-neck (neck width ≥ 4 mm or dome-to-neck ratio \< 2) or fusiform intracranial aneurysms size ≥10 mm 4. Has a vessel diameter ≥ 2.5 mm to ≤ 5.3 mm at both the proximal and distal segments where the implant will be placed 4. Subject is willing to comply with all scheduled follow-up visits and examinations per institutional standard of care
Exclusion criteria
Subject has a major surgery within previous 30 days or planned in the next 120 days after enrollment date 2. Previous intracranial implant associated with the symptomatic distribution within the past 12 weeks prior to treatment date 3. Subject has a non-target aneurysm treated within 30 days prior to study enrollment and a non-target aneurysm that requires treatment within 12 months. 4\. Subject has a planned treatment of a non-target aneurysm in the same vascular territory during participation in the study. 5\. Stenting, angioplasty, or endarterectomy of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days prior to treatment date 6. Any previous coiling where it would interfere with the placement and proper apposition of the device 7. More than one intracranial aneurysm that requires treatment within 12 months 8. Contraindication to CT or MRI scans 9. Subject has severe neurological deficit (mRS score ≥ 3) that renders the subject incapable of living independently 10. Dementia or psychiatric problem that prevents the subject from completing required follow-up 11. Co-morbid conditions that may limit survival to less than 24 months 12. Other known serious concurrent medical conditions such as heart disease (e.g., atrial fibrillation/pacemaker, recent myocardial infarction, symptomatic congestive heart failure, and significant carotid artery disease), pulmonary disease, uncontrolled diabetes, progressive neurologic disorders, vasculitis, or subjects using immunosuppressants including corticosteroids. 13\. Female subjects who are pregnant or planning to become pregnant within the study period (all females of childbearing age must take a pregnancy test within 24 hours of treatment) and who are unwilling or unable to take adequate method of contraception for at least until the 12-month study follow-up\* \*If the subject becomes pregnant during her participation, the physician will have to evaluate the risk associated to her continuing participation to the rest of the study. 14\. Subject does not meet criteria or has any other contraindications listed in the DFU 15. Extra-cranial stenosis or parent vessel with stenosis \>50% in the area proximal to the aneurysm 16. Subject with an intracranial mass (tumor, except meningioma, abscess, or other infection), or is undergoing radiation therapy for carcinoma or sarcoma of the head or neck region 17. Subject had a subarachnoid hemorrhage within 30 days prior to the enrollment date 18. Subject has a non-treated arterio-venous malformation (AVM) in the territory of the target aneurysm 19. Inability to understand the study or a history of non-compliance with medical advice 20. Current use of illicit substance 21. Enrollment in another trial involving an investigational product
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoint. Percentage of subjects experiencing neurological death or major ipsilateral stroke in the treated vascular territory | 12 months | Subjects experiencing neurological death or major ipsilateral stroke in the treated vascular territory through 12 months as adjudicated by an independent Clinical Events Committee (CEC). |
| Primary Efficacy Endpoint. Percentage of subjects with 100% occlusion (Raymond Class 1) without clinically significant stenosis defined as >50% stenosis of the parent artery | 12 months | Subjects with 100% occlusion (Raymond Class 1) without clinically significant stenosis defined as \>50% stenosis of the parent artery based on independent angiographic core laboratory evaluation of 12-month follow-up angiograms and having no retreatment of the target aneurysm through the 12 month follow-up visit timepoint. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Safety Endpoints. Percent of subjects experiencing one or more SAEs | 60 months post-index procedure | The secondary safety endpoint is the percent of subjects experiencing one or more SAEs through 60 months post-index procedure within the following categories (see definitions section of this protocol), as adjudicated by the Clinical Events Committee (CEC): * Device- and procedure-related SAEs at the peri-procedure timepoint and within 60 months of the index procedure as per visit schedule * Key neurological event of interest through 60 months post-procedure |
| Secondary Efficacy Endpoints. Surpass Streamline FDS technical success. The proportion of subjects in whom the Surpass Streamline implant(s) was delivered to cover the aneurysm neck. | Intraoperation | All subjects who, at the end of their procedure, have the target aneurysm neck covered by the Surpass Streamline implant(s) will be considered technical successes. The percent and number of mITT subjects who are technical successes will be reported. |
| Secondary Efficacy Endpoints. Surpass Streamline FDS system success. The proportion of implants successfully delivered to the target location. | Intraoperation | As part of the procedure case report form, investigators are asked if each used Surpass Streamline Flow Diverter was deployed to the target location. The percent and number of Surpass devices that enter a subject and are successfully deployed to the target location will be reported. |
| Secondary Efficacy Endpoints. Re-sheathing performance. The percent and number of Surpass devices that are successfully re-sheathed will be reported. | Intraoperation | As part of the procedure case report form, investigators are asked if the Surpass Streamline Flow Diverter was re-sheathed successfully if the re-sheathing was applied. The percent and number of Surpass devices that are successfully re-sheathed will be reported. |
| Secondary Efficacy Endpoints. Incidence of retreatment through 60 months. The percent and number of mITT subjects who require retreatment, either with the Surpass Streamline Flow Diverter system or with another approach. | 60 months post-procedure | Incidence of retreatment through 60 months |
| Secondary Efficacy Endpoints. The percent and number of mITT subjects who are recorded as having >50% stenosis of the parent artery at the target aneurysm location | 60 months | Parent artery stenosis at the target aneurysm location \>50%. |
| Secondary Efficacy Endpoints. The percent and number of mITT subject who are recorded as having >50% stenosis of their flow diverter | 60 months | In-construct Surpass Streamline FDS stenosis \>50%. |
| Secondary Efficacy Endpoints.The percent and number of mITT subject with any contrast opacification within the treated and previously fully occluded aneurysm on a subsequent angiographic study | 60 months post-procedure | Target aneurysm recanalization |
| Secondary Efficacy Endpoints. Functional status: change in the modified Rankin Scale (mRs) score compared to baseline. Percent of subjects who at follow-up exhibit improvement, worsening, or no change in their modified Rankin score compared to baseline. | 60 months | Functional status: change in the modified Rankin Scale (mRs) score compared to baseline. The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 to 5. A separate category of 6 is usually added for patients who expire. |
| Secondary Efficacy Endpoints.Proportion of subjects with Raymond Class 1, 2 and 3 occlusions.The percent and number of mITT subjects in each Raymond class level at 12 and 36 months will be reported. | 12 and 36 months | Proportion of subjects with Raymond Class 1, 2 and 3 occlusions. Raymond Classification will be determined on subtracted angiographic images as per clinical standard: * Raymond Class 1 = Complete Occlusion * Raymond Class 2 = Residual Neck * Raymond Class 3 = Residual Aneurysm. |
Countries
China
Outcome results
None listed