Surpass Evolve Flow Diverter System: Endovascular treatment with Surpass Evolve Flow Diverter System was performed in patients diagnosed with intracranial aneurysms
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* Subject age is ≥ 18 and ≤80 years
* 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 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:
* 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
Primary outcome measure(s)
Neurological death or disabling stroke — 12 months (-3/ +6 months) post-procedure Neurological death or disabling stroke at 12 months post-procedure (-3/ + 6 months).
* Neurological death defined as stroke-related death
* Disabling stroke defined as stroke in the treated vascular territory that results in a mRS score ≥ 3, assessed by a qualified investigator at a minimum 90-days post stroke event
100% occlusion without significant parent artery stenosis — 12 months (-3/+6 months) post-procedure 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.
Trial sites (24)
Facility
City
Region
Status
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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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