Clinical trial NCT06368622: Evolve China PMCF Study
Official title: A Post-Market Clinical Follow-up Study to Evaluate the Long-Term Safety and Effectiveness of Surpass Evolve Flow Diverter System
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intracranial Aneurysm
Lead sponsor: Stryker Neurovascular
Sponsor class: INDUSTRY
Collaborators: name: Stryker (Beijing) Healthcare Products Co., Ltd
First posted: 2024-04-16
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be enrolled from up to 40 study sites in China.

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.


Eligibility 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

Primary outcomes:
measure: Neurological death or disabling stroke
timeFrame: 12 months (-3/ +6 months) post-procedure
measure: 100% occlusion without significant parent artery stenosis
timeFrame: 12 months (-3/+6 months) post-procedure
Secondary outcomes:
measure: Procedure- and device-related serious adverse events
timeFrame: 60 months
measure: Key neurological events
timeFrame: 60 months
measure: Procedural success
timeFrame: Intraprocedural
measure: Device success
timeFrame: Intraprocedural
measure: Re-sheathing success
timeFrame: Intraprocedural
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical University
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
city: Beijing
country: China
facility: Peking University Third Hospital
city: Changchun
country: China
facility: Bethune First Hospital of Jilin University
city: Kunming
country: China
facility: First Affiliated Hospital of Kunming Medical University
city: Ningbo
country: China
facility: Ningbo Medical Center Lihuili Hospital
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
city: Shanghai
country: China
facility: Shanghai Fourth People's Hospital Affiliated To Tongji University
city: Shenzhen
country: China
facility: South China Hospital of Shenzhen University
city: Shijiazhuang
country: China
facility: The Third Hospital of Hebei Medical University
city: Tangshan
country: China
facility: Tangshan Workers' Hospital
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
city: Xiangyang
country: China
facility: Xiangyang No.1 People's Hospital
city: Zhuhai
country: China
facility: Zhuhai People's Hospital
Study officials:
References: