Evolve China PMCF Study
A Post-Market Clinical Follow-up Study to Evaluate the Long-Term Safety and Effectiveness of Surpass Evolve Flow Diverter System
1 other identifier
observational
500
1 country
24
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2024
Longer than P75 for all trials
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 11, 2024
CompletedFirst Posted
Study publicly available on registry
April 16, 2024
CompletedStudy Start
First participant enrolled
April 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2031
March 30, 2026
March 1, 2026
3.5 years
April 11, 2024
March 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Neurological death or disabling stroke
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
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
Secondary Outcomes (5)
Procedure- and device-related serious adverse events
60 months
Key neurological events
60 months
Procedural success
Intraprocedural
Device success
Intraprocedural
Re-sheathing success
Intraprocedural
Interventions
Endovascular treatment with Surpass Evolve Flow Diverter System was performed in patients diagnosed with intracranial aneurysms
Eligibility Criteria
The study population will be enrolled from up to 40 study sites in China.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Xuanwu Hospital Capital Medical University
Beijing, 100053, China
Beijing Tiantan Hospital, Capital Medical University
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2024
First Posted
April 16, 2024
Study Start
April 24, 2024
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
August 1, 2031
Last Updated
March 30, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share