china surpass streamline post-market study

Conditions: Aneurysm, Intracranial

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.

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:
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