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

STATUS

Recruiting
End date

Jul 31, 2025
participants needed

235
sponsor

Stryker Neurovascular

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Updated on 10 October 2022

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diabetes

ruptured aneurysm

hypertension

subarachnoid hemorrhage

Summary

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

Description

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.

Details

Condition	Aneurysm, Intracranial
Treatment	Surpass Evolve Flow Diverter System
Clinical Study Identifier	NCT04195568
Sponsor	Stryker Neurovascular
Last Modified on	10 October 2022

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Eligibility		Yes	No	Not Sure
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
	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
	segments where the implant will be placed
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
	Received previous treatment of the target aneurysm or parent artery where it would interfere with the placement or proper apposition of the device
	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
	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 acute life-threatening illness other than the neurological disease (e.g., acute kidney or heart failure) to be treated in this trial
	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
	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

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