Aneurysm, IntracranialNCT05544045
China Surpass Streamline Post-Market Study
An observational study of Aneurysm, Intracranial, run by Stryker Neurovascular at 15 sites in China.
Trial 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 ≥… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aneurysm, Intracranial
- What is being tested?
- Surpass Streamline Flow Diverter System
- Type of treatment
- Medical device
- How many people
- 11 participants
- Where
- 15 sitesChina
- Study dates
- 3 Jun 2022to 30 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Enrolled, Not Treated (ENT) Population All subjects who sign the informed consent are considered enrolled and will be further screened by an angiogram to determine study eligibility. All subjects who are enrolled, have the pre-treatment angiogram, but never have the device enter their body, will be part of the Enrolled, Not Treated, angiogram (ENTa) population. For subjects that are enrolled, but exit the study before the pre-procedure angiogram, will be included in the Enrolled, Not Treated, no angiogram (ENTna) population. Members of the ENTna population will be followed to the time of study exit. Modified Intent to Treat Population The modified Intent to Treat (mITT) population will include all enrolled subjects for whom the Surpass Streamline FDS entered the body, regardless of deployment. The mITT subjects will be followed up to 5 years per protocol. Primary safety and efficacy analyses will be completed on the mITT population.
Who may be able to join
- 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:
- Is located in the internal carotid artery (ICA) distribution from petrous segment up to the terminus
- Is able to be crossed with a standard 0.014" guide wire
- Has unruptured saccular wide-neck (neck width ≥ 4 mm or dome-to-neck ratio < 2) or fusiform intracranial aneurysms size ≥10 mm
- 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
Who cannot join
- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
China15 sites
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality
Hunan Provincial People's Hospital
Changsha, Hunan
The Third Xiangya Hospital of Central South University
Changsha, Hunan
Xiangya Hospital of Central South University
Changsha, Hunan
The Second Affiliated Hospital of Guilin Medical College
Guilin, Guangxi
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi
The Affiliated Hospital of Qingdao University
Qingdao, Shandong
Shenzhen Second People's Hospital
Shenzhen, Guangdong
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei
Tangdu Hospital
Xi'an, Shaanxi
Xijing Hospital
Xi'an, Shaanxi
Henan Provincial People's Hospita
Zhengzhou, Henan
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Zhuhai People's Hospital
Zhuhai, Guangdong
About this study
Official title: Endovascular Treatment of Patients in China With the Surpass Streamline Flow Diverter for Unruptured Large and Giant Saccular Wide-Neck or Fusiform Intracranial Aneurysms in the Internal Carotid Artery
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.
Read the 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.
- Conditions
- Aneurysm, Intracranial
- Being tested
- Surpass Streamline Flow Diverter System
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surpass Streamline Flow Diverter SystemDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint. Percentage of subjects experiencing neurological death or major ipsilateral stroke in the treated vascular territory
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).
Measured: 12 months
Primary Efficacy Endpoint. Percentage of subjects with 100% occlusion (Raymond Class 1) without clinically significant stenosis defined as >50% stenosis of the parent artery
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.
Measured: 12 months
Secondary outcomes (10)
Secondary Safety Endpoints. Percent of subjects experiencing one or more SAEs
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
Measured: 60 months post-index 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.
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.
Measured: Intraoperation
Secondary Efficacy Endpoints. Surpass Streamline FDS system success. The proportion of implants successfully delivered to the target location.
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.
Measured: Intraoperation
Secondary Efficacy Endpoints. Re-sheathing performance. The percent and number of Surpass devices that are successfully re-sheathed will be reported.
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.
Measured: Intraoperation
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.
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.
Measured: 60 months
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.
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.
Measured: 12 and 36 months
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.
Incidence of retreatment through 60 months
Measured: 60 months post-procedure
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
Parent artery stenosis at the target aneurysm location >50%.
Measured: 60 months
Secondary Efficacy Endpoints. The percent and number of mITT subject who are recorded as having >50% stenosis of their flow diverter
In-construct Surpass Streamline FDS stenosis >50%.
Measured: 60 months
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
Target aneurysm recanalization
Measured: 60 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 Sep 2022
- Study start3 Jun 2022
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Why it stopped: Slow Enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneurysm, IntracranialStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Neurovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Stryker (Beijing) Healthcare Products Co., Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05544045
- Sponsor's protocol ID
- NV00050330
- Status last verified
- Feb 2025
- First submitted
- 17 Jun 2022
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Terminated study with limited enrollments
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovascular Treatment of Patients in China With the Surpass Streamline Flow Diverter for Unruptured Large and Giant Saccular Wide-Neck or Fusiform Intracranial Aneurysms in the Internal Carotid Artery
- ClinicalTrials.gov ID
- NCT05544045
- Acronym / sponsor ID
- NV00050330
- Conditions
- Aneurysm, Intracranial
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow Enrollment
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Stryker NeurovascularIndustry (pharma, biotech, devices)
- Collaborators
- Stryker (Beijing) Healthcare Products Co., Ltd
- Study start
- 3 Jun 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 16 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Enrolled, Not Treated (ENT) Population All subjects who sign the informed consent are considered enrolled and will be further screened by an angiogram to determine study eligibility. All subjects who are enrolled, have the pre-treatment angiogram, but never have the device enter their body, will be part of the Enrolled, Not Treated, angiogram (ENTa) population. For subjects that are enrolled, but exit the study before the pre-procedure angiogram, will be included in the Enrolled, Not Treated, no angiogram (ENTna) population. Members of the ENTna population will be followed to the time of study exit. Modified Intent to Treat Population The modified Intent to Treat (mITT) population will include all enrolled subjects for whom the Surpass Streamline FDS entered the body, regardless of deployment. The mITT subjects will be followed up to 5 years per protocol. Primary safety and efficacy analyses will be completed on the mITT population.
Key inclusion criteria (5 listed)
- 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:
- Is located in the internal carotid artery (ICA) distribution from petrous segment up to the terminus
- Is able to be crossed with a standard 0.014" guide wire
- Has unruptured saccular wide-neck (neck width ≥ 4 mm or dome-to-neck ratio < 2) or fusiform intracranial aneurysms size ≥10 mm
- 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
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Surpass Streamline Flow Diverter SystemThe 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. | Device | – |
Primary outcome
Primary Safety Endpoint. Percentage of subjects experiencing neurological death or major ipsilateral stroke in the treated vascular territory
Time frame: 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
Time frame: 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.
10 secondary outcomes
Secondary Safety Endpoints. Percent of subjects experiencing one or more SAEs
Time frame: 60 months post-index 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.
Time frame: Intraoperation
Secondary Efficacy Endpoints. Surpass Streamline FDS system success. The proportion of implants successfully delivered to the target location.
Time frame: Intraoperation
Secondary Efficacy Endpoints. Re-sheathing performance. The percent and number of Surpass devices that are successfully re-sheathed will be reported.
Time frame: Intraoperation
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.
Time frame: 60 months
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.
Time frame: 12 and 36 months
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.
Time frame: 60 months post-procedure
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
Time frame: 60 months
Secondary Efficacy Endpoints. The percent and number of mITT subject who are recorded as having >50% stenosis of their flow diverter
Time frame: 60 months
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
Time frame: 60 months post-procedure
Results and safety
The study was stopped early (reason given: Slow Enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Individual participant dataSharing planned: No. Terminated study with limited enrollments
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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.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aneurysm, Intracranial, run by Stryker Neurovascular at 15 sites in China.
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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in China. 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?
The study was stopped early (reason given: Slow Enrollment). Results are not available in the source record.
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?
Primary Safety Endpoint. Percentage of subjects experiencing neurological death or major ipsilateral stroke in the treated vascular territory (time frame: 12 months). 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?
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 7 Feb 2025.