Observational follow-up for patients with intracranial aneurysms treated with a specific flow diverter system
A Post-Market Clinical Follow-up Study to Evaluate the Long-Term Safety and Effectiveness of Surpass Evolve Flow Diverter System
This study is following patients with brain aneurysms who have been treated with a special flow diverter to see how well it works and if it keeps them safe over the next several years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Stryker Neurovascular Industry-sponsored |
| Locations | 16 sites (Beijing and 15 other locations) |
| Trial ID | NCT06368622 on ClinicalTrials.gov |
What this trial studies
This observational study aims to follow patients with intracranial aneurysms who are treated with the Surpass Evolve Flow Diverter System. It is a multi-center, single-arm study that will monitor subjects over a period of up to 8 years, including 5 years of follow-up. Participants will be assessed according to standard care protocols at each study site to evaluate the long-term outcomes of the treatment. The study is designed to gather real-world data on the safety and effectiveness of the device in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 80 who are eligible for treatment with the Surpass Evolve Flow Diverter System.
Not a fit: Patients with recent treatment of non-target intracranial aneurysms or those with acute aneurysm rupture may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term safety and effectiveness of the Surpass Evolve Flow Diverter System for treating intracranial aneurysms.
How similar studies have performed: While this study follows a well-established treatment approach, the specific observational design and long-term follow-up may provide novel insights into patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Beijing and 15 other locations
- Xuanwu Hospital Capital Medical University — Beijing, China (Recruiting)
- Beijing Tiantan Hospital, Capital Medical University — Beijing, China (Recruiting)
- Peking University Third Hospital — Beijing, China (Active_not_recruiting)
- Bethune First Hospital of Jilin University — Changchun, China (Recruiting)
- First Affiliated Hospital of Kunming Medical University — Kunming, China (Recruiting)
- Ningbo Medical Center Lihuili Hospital — Ningbo, China (Recruiting)
- The Affiliated Hospital of Qingdao University — Qingdao, China (Recruiting)
- The Affiliated Hospital of Qingdao University — Qingdao, China (Recruiting)
- The Affiliated Hospital of Qingdao University — Qingdao, China (Recruiting)
- Shanghai Fourth People's Hospital Affiliated To Tongji University — Shanghai, China (Recruiting)
- South China Hospital of Shenzhen University — Shenzhen, China (Recruiting)
- The Third Hospital of Hebei Medical University — Shijiazhuang, China (Recruiting)
- Tangshan Workers' Hospital — Tangshan, China (Recruiting)
- The First Affiliated Hospital of Xi'an Jiaotong University — Xi'an, China (Recruiting)
- Xiangyang No.1 People's Hospital — Xiangyang, China (Recruiting)
- Zhuhai People's Hospital — Zhuhai, China (Recruiting)
Study contacts
- Study coordinator: Mingyao Zheng
- Email: peter.zheng@stryker.cn
- Phone: +86 13761826075
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.