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.
Study Type
OBSERVATIONAL
Enrollment
11
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.
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
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).
Time frame: 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.
Time frame: 12 months
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
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.
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.
Time frame: Intraoperation
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Shenzhen Second People's Hospital
Shenzhen, Guangdong, China
Zhuhai People's Hospital
Zhuhai, Guangdong, China
The Second Affiliated Hospital of Guilin Medical College
Guilin, Guangxi, China
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Henan Provincial People's Hospita
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Hunan Provincial People's Hospital
Changsha, Hunan, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
...and 5 more locations
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.
Time frame: 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.
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.
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.
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.
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.
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.
Incidence of retreatment through 60 months
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
Parent artery stenosis at the target aneurysm location \>50%.
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
In-construct Surpass Streamline FDS stenosis \>50%.
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
Target aneurysm recanalization
Time frame: 60 months post-procedure