Evaluation of Safety and Effectiveness of Stryker Surpass Evolve™ Flow Diverter System

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the safety and effectiveness of the Surpass™ Evolve Flow Diverter System in the treatment of unruptured, wide-neck intracranial aneurysms measuring ≤ 12 mm and located on the ICA or its branches

Detailed Description
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The Surpass Evolve Flow Diverter System is indicated for the endovascular treatment of adults (age 18 or above) with unruptured saccular wide-neck or fusiform intracranial aneurysms ≤ 12 mm for treatment in vessel diameters between 1.75-5.0mm.

Official Title
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EndoVascular Treatment Of Wide-Neck Aneurysms, an EvaLuation of Safety and EffectiVeness of Stryker Surpass Evolve™ Flow Diverter System

Conditions
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Aneurysm, Intracranial

Intervention / Treatment
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* Device: Surpass Evolve Flow Diverter System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age is ≥ 18 and ≤ 80 years Has a single unruptured target intracranial aneurysm (IA) with the following characteristics: Is located on the internal carotid artery (ICA) or its branches. Has a neck ≥ 4 mm, dome to neck ratio ≤ 2.0, or no discernible neck Aneurysm size is ≤ 12 mm (saccular or fusiform configuration) Has a parent vessel diameter ≥ 1.75 mm and ≤ 5.0 mm at both the proximal and distal segments where the implant will be placed Has multiple increased risk factors for intracranial (IA) aneurysm rupture, including but not limited to, aneurysm morphology, smoking, hypertension, diabetes, age, prior and/or family history of rupture, and/or history of subarachnoid hemorrhage that may result in a benefit risk profile of endovascular treatment that outweighs the risks of intracranial aneurysm rupture during the subject's expected lifetime if left untreated. Exclusion Criteria: Has an extradural target aneurysm Has a target aneurysm in the posterior circulation Perforator or branch vessel, inclusive of the posterior communicating artery, arises from the target aneurysm body or neck (branches or arteries must arise or connect from the parent vessel separate from the aneurysm or neck to not be excluded from study) Has a true bifurcation aneurysm, defined as an aneurysm (saccular or non-saccular) located at a point of vessel bifurcation Target aneurysm is unsuitable for flow diverter treatment Has vessel characteristics, such as severe tortuosity (cICA Type IV), stenosis (>70%), or morphology that would preclude safe endovascular access to the target aneurysm necessary for treatment with the study device Received previous treatment of the target aneurysm or parent artery where it would interfere with the placement or proper apposition of the device Has a medical contraindication to study or procedure related antiplatelet medications (aspirin, clopidogrel/Plavix, ticagrelor, and heparin), local or general anesthesia, or life-threatening allergy to contrast dye Has a known severe allergy to nickel, chromium cobalt, tungsten or platinum. Modified Rankin Score (mRS) assessment is ≥ 3 at preprocedure exam Presence of unstable neurological deficit (i.e., worsening of clinical condition in the last 30 days) Subarachnoid hemorrhage occurred within 30 days prior to enrollment Major surgery (including previous intracranial implant) occurred within previous 30 days or is planned in the next 120 days after enrollment date Has more than one IA that requires treatment within 12 months Received previous intracranial implant associated with the symptomatic or vascular distribution within the past 12 weeks prior to treatment date Chronic anticoagulation therapy is ongoing or known coagulopathy exists Has other known serious concurrent medical conditions such as heart disease (e.g., unstable atrial fibrillation [with or without pacemaker], recent myocardial infarction [< 12 weeks ago], symptomatic congestive heart failure, or carotid stenosis), kidney failure [>2.0mg/dl serum creatinine], pulmonary disease, uncontrolled diabetes, progressive neurologic disorders, terminal cancer, vasculitis, high risk of ischemic stroke or recent stroke Has acute life-threatening illness other than the neurological disease (e.g., acute kidney or heart failure) to be treated in this trial Life expectancy is less than 5 years due to other illness or condition (in addition to an intracranial aneurysm) Unable to complete study follow up due to dementia or psychiatric problem, substance abuse, or history of noncompliance with medical advice Pregnancy at time of enrollment Presence of intracranial mass (tumor, except meningioma, abscess, or other infection), non-treated arteriovenous malformation (AVM) in the territory of the target aneurysm Evidence of active infection at the time of treatment Enrollment in another trial involving an investigational product that could confound the outcomes of this trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surpass Evolve Flow Diverter System<br>This is a prospective single arm study in which all subjects who present for flow diverter implantation, provide informed consent, and meet inclusion/exclusion criteria may receive treatment (Surpass Evolve Flow Diverter). | Device: Surpass Evolve Flow Diverter System<br>* The Surpass Evolve Flow Diverter System is indicated for the endovascular treatment of adults (age 18 or above) with unruptured saccular wide-neck or fusiform intracranial aneurysms ≤12 mm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Effectiveness Endpoint | The primary effectiveness endpoint of this study is a composite of 100% occlusion (Raymond 1, complete occlusion) of the target aneurysm without significant parent artery stenosis (>50% stenosis), per independent core lab assessment of digital subtraction angiography (DSA) images acquired at 12 months (± 3 months) post-procedure, and with no target aneurysm retreatment. | 12 months (± 3 months) post procedure | 
| Primary Safety Endpoint | The primary safety endpoint of this study is neurologic death, or disabling stroke at 12 months as adjudicated by an independent Clinical Events Committee (CEC). | 12 Months (± 3 months) post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Safety Endpoints | The secondary safety endpoints will be evaluated throughout the study, and are as follows: Neurological death or major ipsilateral stroke as adjudicated by an independent Clinical Events Committee. Stroke in the treated vascular territory as adjudicated by a Clinical Events Committee | 3 Year Follow-Up |