Evolve China PMCF Study

N/AActive Not RecruitingNCT06368622

Stryker Neurovascular500 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Intracranial Aneurysm

Interventions

Surpass Evolve Flow Diverter SystemDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (24)

Xuanwu Hospital Capital Medical University

Beijing, China

Outcomes

Primary Outcomes

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

Time frame: 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.

Time frame: 12 months (-3/+6 months) post-procedure

Secondary Outcomes

Procedure- and device-related serious adverse events

Procedure- and device-related serious adverse events through 60 months post-procedure

Time frame: 60 months

Key neurological events

Key neurological events of interest through 60 months post-procedure

Time frame: 60 months

Procedural success

Delivery and deployment of one or more study devices to completely cover the neck of the target aneurysm in an individual subject.

Time frame: Intraprocedural

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.

Time frame: Intraprocedural

Data from ClinicalTrials.gov

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