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| Name | Class |
|---|---|
| Stryker (Beijing) Healthcare Products Co., Ltd | INDUSTRY |
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A prospective, multi-center, single-arm, open-label, observational, post-market clinical follow-up. The expected duration of the study is 8 years (including up to 5-years' follow-up). Each subject will be followed up per standard of care (SoC) at each study site.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surpass Evolve Flow Diverter System | Device | Endovascular treatment with Surpass Evolve Flow Diverter System was performed in patients diagnosed with intracranial aneurysms |
| Measure | Description | Time Frame |
|---|---|---|
| Neurological death or disabling stroke | Neurological death or disabling stroke at 12 months post-procedure (-3/ + 6 months).
| 12 months (-3/ +6 months) post-procedure |
| 100% occlusion without significant parent artery stenosis | A composite of 100% occlusion (defined as Raymond-Roy class 1) of the target aneurysm without significant parent artery stenosis (significant stenosis defined as ˃50% stenosis), per the assessment of images required, and with no retreatment of target aneurysm at 12 months (-3/+6 months) post-procedure. | 12 months (-3/+6 months) post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure- and device-related serious adverse events | Procedure- and device-related serious adverse events through 60 months post-procedure | 60 months |
| Key neurological events | Key neurological events of interest through 60 months post-procedure |
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Inclusion Criteria:
Exclusion Criteria:
Subject has any non-target intracranial aneurysm treated within 30 days prior to study enrollment
Subject has a planned treatment of a non-target aneurysm in the same vascular territory during participation in the study within 12 months post procedure
Subject has undergone previous treatment where it would interfere with the delivery and/ or placement and/or proper apposition of Surpass Evolve FDS
Subject has acute target aneurysm rupture and/or subarachnoid hemorrhage occurred within 30 days prior to enrollment
Subject has any condition demonstrated as Warning or Precautions in IFU
Antiplatelet and/or anticoagulation therapy (e.g. aspirin and clopidogrel) is contraindicated for the subject
Subject has not received dual anti-platelet agents prior to the procedure
Subject with an active bacterial infection
Subject in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as:
Female subjects who are pregnant/ nursing, or who are unwilling or unable to take adequate method of contraception prior to 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.
Enrollment in another trial involving an investigational product and/or drug interfere with study procedure/ results
The investigator determined that the health of the patient may be compromised by the patient's enrollment
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The study population will be enrolled from up to 40 study sites in China.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital Capital Medical University | Beijing | 100053 | China | |||
| Beijing Tiantan Hospital, Capital Medical University |
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| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| 60 months |
| Procedural success | Delivery and deployment of one or more study devices to completely cover the neck of the target aneurysm in an individual subject. | Intraprocedural |
| Device success | Delivery and deployment of a study device to completely cover the neck of the target aneurysm, either alone or in conjunction with another Surpass Evolve FDS. | Intraprocedural |
| Re-sheathing success | Successful re-sheathing with single attempt. | Intraprocedural |
| Beijing |
| 100070 |
| China |
| Peking University Third Hospital | Beijing | 100191 | China |
| Beijing Chao-Yang Hospital, Capital Medical University | Beijing | China |
| Bethune First Hospital of Jilin University | Changchun | 130021 | China |
| The First Affiliated Hospital of Fujian Medical University | Fuzhou | China |
| Guangdong Second Provincial General Hospital | Guangzhou | China |
| First Affiliated Hospital of Kunming Medical University | Kunming | 650032 | China |
| Nanyang Central Hospital | Nanyang | China |
| Ningbo Medical Center Lihuili Hospital | Ningbo | 315048 | China |
| The Affiliated Hospital of Qingdao University | Qingdao | 266003 | China |
| The Affiliated Hospital of Qingdao University | Qingdao | 266100 | China |
| The Affiliated Hospital of Qingdao University | Qingdao | 266500 | China |
| Shanghai Fourth People's Hospital Affiliated To Tongji University | Shanghai | 200434 | China |
| South China Hospital of Shenzhen University | Shenzhen | 518111 | China |
| The Eighth Affiliated Hospital, Sun Yat-sen University (Shenzhen Futian) | Shenzhen | China |
| The Third Hospital of Hebei Medical University | Shijiazhuang | 050051 | China |
| Tangshan Workers' Hospital | Tangshan | 063000 | China |
| Tianjin Huanhu Hospital | Tianjin | China |
| Weifang People's Hospital | Weifang | China |
| The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | 710061 | China |
| Xiangyang No.1 People's Hospital | Xiangyang | 441000 | China |
| Zhuhai People's Hospital | Zhuhai | 519000 | China |
| The Fifth Affiliated Hospital, Sun Yat-sen University | Zhuhai | China |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |