Intracranial Aneurysm
Conditions
Keywords
intracranial aneurysms, flow diverter system, Surpass Evolve Flow Diverter System, Surpass Evolve
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.
Interventions
Endovascular treatment with Surpass Evolve Flow Diverter System was performed in patients diagnosed with intracranial aneurysms
Sponsors
Stryker Neurovascular
Stryker (Beijing) Healthcare Products Co., Ltd
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neurological death or disabling stroke | 12 months (-3/ +6 months) post-procedure | 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 |
| 100% occlusion without significant parent artery stenosis | 12 months (-3/+6 months) post-procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure- and device-related serious adverse events | 60 months | Procedure- and device-related serious adverse events through 60 months post-procedure |
| Key neurological events | 60 months | Key neurological events of interest through 60 months post-procedure |
| Procedural success | Intraprocedural | Delivery and deployment of one or more study devices to completely cover the neck of the target aneurysm in an individual subject. |
| Device success | Intraprocedural | 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. |
| Re-sheathing success | Intraprocedural | Successful re-sheathing with single attempt. |
Countries
China
Outcome results
None listed