Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2024-04-24
2031-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Surpass Evolve Flow Diverter System
Endovascular treatment with Surpass Evolve Flow Diverter System was performed in patients diagnosed with intracranial aneurysms
Eligibility Criteria
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Inclusion Criteria
* Subject is eligible for Surpass Evolve FDS IFU, and/or physician intends to treat the subject with Surpass Evolve FDS per his/her judgement
* Subject, or subject's legally authorised representative (LAR) has provided signed informed consent using the Ethics Committee (EC)-approved consent form
* Subject is willing to comply with scheduled visits and examinations per institutional SOC
Exclusion Criteria
* 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:
* Severe intracranial vessel tortuosity or stenosis; and/or
* Intracranial vasospasm not responsive to medical therapy
* 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
18 Years
80 Years
ALL
No
Sponsors
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Stryker (Beijing) Healthcare Products Co., Ltd
INDUSTRY
Stryker Neurovascular
INDUSTRY
Responsible Party
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Locations
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Xuanwu Hospital Capital Medical University
Beijing, , China
Beijing Tiantan Hospital, Capital Medical University
Beijing, , China
Peking University Third Hospital
Beijing, , China
Beijing Chao-Yang Hospital, Capital Medical University
Beijing, , China
Bethune First Hospital of Jilin University
Changchun, , 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, , China
Nanyang Central Hospital
Nanyang, , China
Ningbo Medical Center Lihuili Hospital
Ningbo, , China
The Affiliated Hospital of Qingdao University
Qingdao, , China
The Affiliated Hospital of Qingdao University
Qingdao, , China
The Affiliated Hospital of Qingdao University
Qingdao, , China
Shanghai Fourth People's Hospital Affiliated To Tongji University
Shanghai, , China
South China Hospital of Shenzhen University
Shenzhen, , China
The Eighth Affiliated Hospital, Sun Yat-sen University (Shenzhen Futian)
Shenzhen, , China
The Third Hospital of Hebei Medical University
Shijiazhuang, , China
Tangshan Workers' Hospital
Tangshan, , China
Tianjin Huanhu Hospital
Tianjin, , China
Weifang People's Hospital
Weifang, , China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, , China
Xiangyang No.1 People's Hospital
Xiangyang, , China
Zhuhai People's Hospital
Zhuhai, , China
The Fifth Affiliated Hospital, Sun Yat-sen University
Zhuhai, , China
Countries
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Central Contacts
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Facility Contacts
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Hongqi Zhang
Role: primary
Ming Lv
Role: primary
Yang Wang
Role: primary
Honglei Wang
Role: primary
Yuanxiang Lin
Role: primary
Xuying He
Role: primary
Peng Bai
Role: primary
Changming Wen
Role: primary
Maosong Chen
Role: primary
Rui Xu
Role: primary
Zhiyong Yan
Role: primary
Yong Zhang
Role: primary
Yibin Fang
Role: primary
Shiwei Du
Role: primary
Bin Luo
Role: primary
Pinyuan Zhang
Role: primary
Xiang Xu
Role: primary
Hongguang Wang
Role: primary
Zengwu Wang
Role: primary
Jianfeng Han
Role: primary
Peiyang Zhou
Role: primary
Guangsen Cheng
Role: primary
Other Identifiers
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CDM10001814
Identifier Type: -
Identifier Source: org_study_id