China Surpass Streamline Post-Market Study

NCT05544045 | Terminated

• 1 other identifier: NV00050330
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 15

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.

Conditions

Aneurysm, Intracranial

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  12 months

Secondary Outcomes (10)

• Secondary Safety Endpoints. Percent of subjects experiencing one or more SAEs

  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.

  Intraoperation

• Secondary Efficacy Endpoints. Surpass Streamline FDS system success. The proportion of implants successfully delivered to the target location.

  Intraoperation

• Secondary Efficacy Endpoints. Re-sheathing performance. The percent and number of Surpass devices that are successfully re-sheathed will be reported.

  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.

  60 months

Interventions

Surpass Streamline Flow Diverter System DEVICE

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• \. 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

You may not qualify if:

• 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.
• \. Subject has a planned treatment of a non-target aneurysm in the same vascular territory during participation in the study.
• \. 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.
• \. 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.
• \. 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

Sponsors & Collaborators

• Stryker Neurovascular: lead
• Stryker (Beijing) Healthcare Products Co., Ltd: collaborator

Study Sites (15)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, China

Location

Shenzhen Second People's Hospital

Shenzhen, Guangdong, China

Location

Zhuhai People's Hospital

Zhuhai, Guangdong, China

Location

The Second Affiliated Hospital of Guilin Medical College

Guilin, Guangxi, China

Location

The Third Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location

Henan Provincial People's Hospita

Zhengzhou, Henan, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

Hunan Provincial People's Hospital

Changsha, Hunan, China

Location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, China

Location

Tangdu Hospital

Xi'an, Shaanxi, China

Location

Xijing Hospital

Xi'an, Shaanxi, China

Location

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Location

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: September 16, 2022
• Study Start: June 3, 2022
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (15)