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Clinical Trials in China / NCT06368622
Active, not recruiting Observational

Evolve China PMCF Study

NCT06368622 · tracked via the Priya Life Science China tracker
Sponsor
Stryker Neurovascular
Phase
Observational
Started
2024-04-24
Last updated
2026-03-30

Condition(s) studied

Intracranial Aneurysm

Investigational drug(s) / intervention(s)

Surpass Evolve Flow Diverter System

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)

Trial sites (24)

FacilityCityRegionStatus
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

Other trials for the same condition

Official registry record

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.

View NCT06368622 on ClinicalTrials.gov ↗ ← All trials in China