Evolve China PMCF Study

Intracranial Aneurysm Clinical Trial

Official title:

Post-Market Clinical Follow-up Study to Evaluate the Long-Term Safety and Effectiveness of Surpass Evolve Flow Diverter System: A Real-World Registry

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06368622
• Other study ID #: CDM10001814
• Status: Not yet recruiting
• Start date: April 2024
• Est. completion date: August 2031

Study information

• Verified date: April 2024
• Source: Stryker Neurovascular
• Contact: Mingyao Zheng
• Phone: 13761826075
• Email: peter.zheng[@]stryker.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A prospective, multi-center, single-arm, open-label, observational post-market real-world registry. The expected duration of the study is 8 years (including up to 5-years' follow-up).

Each subject will be followed in accordance with the standard of care (SOC) at each participating hospital.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: August 2031
• Est. primary completion date: November 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 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 planning to become pregnant within the study period must have a documented negative pregnancy test within one week prior to enrollment *

*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 study procedure/ results

• The investigator determined that the health of the patient may be compromised by the patient's enrollment

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Intervention

Device:
• Surpass Evolve Flow Diverter System
Endovascular treatment with Surpass Evolve Flow Diverter System was performed in patients diagnosed with intracranial aneurysms

Locations

Country	Name	City	State
China	Xuanwu Hospital Capital Medical University	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Stryker Neurovascular	Stryker (Beijing) Healthcare Products Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Procedure- and device-related serious adverse events	Procedure- and device-related serious adverse events through 60 months post-procedure	60 months
Secondary	Key neurological events	Key neurological events of interest through 60 months post-procedure	60 months
Secondary	Procedural success	Delivery and deployment of one or more study devices to completely cover the neck of the target aneurysm in an individual subject.	Intraprocedural
Secondary	Device success	Delivery and deployment of a study device to completely cover the neck of the target aneurysm, either alone or in conjunction with another Surpass Evolve FDS.	Intraprocedural
Secondary	Re-sheathing success	Successful re-sheathing with single attempt.	Intraprocedural