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

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ClinicalTrials.gov Identifier: NCT04195568
Recruitment Status : Recruiting
First Posted : December 12, 2019
Last Update Posted : February 16, 2021
Sponsor:
Information provided by (Responsible Party):
Stryker Neurovascular

Brief 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

Condition or disease Intervention/treatment Phase
Aneurysm, Intracranial Device: Surpass Evolve Flow Diverter System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 235 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: EndoVascular Treatment Of Wide-Neck Aneurysms, an EvaLuation of Safety and EffectiVeness of Stryker Surpass Evolve™ Flow Diverter System
Actual Study Start Date : July 7, 2020
Estimated Primary Completion Date : July 28, 2023
Estimated Study Completion Date : July 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Arm Intervention/treatment
Experimental: Surpass Evolve Flow Diverter System
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
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.




Primary Outcome Measures :
  1. Primary Effectiveness Endpoint [ Time Frame: 12 months (± 3 months) post procedure ]
    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.

  2. Primary Safety Endpoint [ Time Frame: 12 Months (± 3 months) post procedure ]
    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).


Secondary Outcome Measures :
  1. Secondary Safety Endpoints [ Time Frame: 3 Year Follow-Up ]

    The secondary safety endpoints will be evaluated throughout the study, and are as follows:

    1. Neurological death or major ipsilateral stroke as adjudicated by an independent Clinical Events Committee.
    2. Stroke in the treated vascular territory as adjudicated by a Clinical Events Committee



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age is ≥ 18 and ≤ 80 years
  2. Has a single unruptured target intracranial aneurysm (IA) with the following characteristics:

    1. Is located on the internal carotid artery (ICA) or its branches.
    2. Has a neck ≥ 4 mm, dome to neck ratio ≤ 2.0, or no discernible neck
    3. Aneurysm size is ≤ 12 mm (saccular or fusiform configuration)
  3. 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
  4. 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:

  1. Has an extradural target aneurysm
  2. Has a target aneurysm in the posterior circulation
  3. 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)
  4. Has a true bifurcation aneurysm, defined as an aneurysm (saccular or non-saccular) located at a point of vessel bifurcation
  5. Target aneurysm is unsuitable for flow diverter treatment
  6. Has vessel characteristics, such as severe tortuosity, stenosis, or morphology that would preclude safe endovascular access to the target aneurysm necessary for treatment with the study device (e.g., which may be evidenced by excessive resistance felt during the procedure); or, presence of intracranial atherosclerotic disease or stenosis
  7. Received previous treatment of the target aneurysm or parent artery where it would interfere with the placement or proper apposition of the device
  8. Has a medical contraindication to study or procedure related antiplatelet medications (aspirin, clopidogrel/Plavix, ticagrelor, and heparin), local or general anesthesia, or lifethreatening allergy to contrast dye
  9. Has a known severe allergy to nickel, chromium cobalt, tungsten or platinum.
  10. Modified Rankin Score (mRS) assessment is ≥ 3 at preprocedure exam
  11. Presence of unstable neurological deficit (i.e., worsening of clinical condition in the last 30 days)
  12. Subarachnoid hemorrhage occurred within 30 days prior to enrollment
  13. Major surgery (including previous intracranial implant) occurred within previous 30 days or is planned in the next 120 days after enrollment date
  14. Has more than one IA that requires treatment within 12 months
  15. Received previous intracranial implant associated with the symptomatic or vascular distribution within the past 12 weeks prior to treatment date
  16. Chronic anticoagulation therapy is ongoing or known coagulopathy exists
  17. Has other known serious concurrent medical conditions such as heart disease (including atrial fibrillation, pacemaker, recent myocardial infarction [< 12 weeks], 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
  18. Has acute life-threatening illness other than the neurological disease (e.g., acute kidney or heart failure) to be treated in this trial
  19. Life expectancy is less than 5 years due to other illness or condition (in addition to an intracranial aneurysm)
  20. Unable to complete study follow up due to dementia or psychiatric problem, substance abuse, or history of noncompliance with medical advice
  21. Pregnancy at time of enrollment
  22. Presence of intracranial mass (tumor, except meningioma, abscess, or other infection), non-treated arteriovenous malformation (AVM) in the territory of the target aneurysm

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04195568


Contacts
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Contact: Chris Butler 470 419 0111 chris.butler@stryker.com
Contact: Scott Courts 925 519 7483 scott.courts@stryker.com

Locations
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United States, Arizona
DIGNITY HEALTH/ Barrow Neurological Institute Recruiting
Phoenix, Arizona, United States, 85013
Contact: Margaret McCauley         
St. Joseph's Hospital Recruiting
Tucson, Arizona, United States, 85711
Contact: Rachael Taoka         
United States, Florida
Lyerly Baptist, Inc./Baptist Medical Center - Jacksonville/Lyerly Neurosurgery Recruiting
Jacksonville, Florida, United States, 32207
Contact: Nancy Ebreo         
United States, Illinois
Advocate Lutheran General Hospital Recruiting
Park Ridge, Illinois, United States, 60068
Contact: Gina Littlejohn         
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Lauren Snyder         
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Heena Olalde         
United States, Kentucky
Baptist Healthcare System, Inc./Baptist Health Recruiting
Lexington, Kentucky, United States, 40503
Contact: Mandy Cano         
United States, Maine
Maine Medical Center Recruiting
Portland, Maine, United States, 04102
Contact: Deborah Cushing         
United States, Massachusetts
Lahey Clinic Recruiting
Burlington, Massachusetts, United States, 01805
Contact: Deborah Gannon         
United States, New York
ICAHN School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Serina Deeba         
United States, Tennessee
Semmes Murphey Clinic/ University of Tennessee Health Sciences Center Recruiting
Memphis, Tennessee, United States, 38120
Contact: Jessica Ward         
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Charlotte Gilman         
Australia, Queensland
Gold Coast Hospital & Health Service/ Gold Coast University Hospital Recruiting
Southport, Queensland, Australia, 4215
Contact: Cheryl Rapier         
Canada, Ontario
University Health Network/ Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Alex Kostynskyy         
Sponsors and Collaborators
Stryker Neurovascular
Investigators
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Principal Investigator: Adam S Arthur, MD Semmes Murphy Clinic
Principal Investigator: Vitor M Pereira, MD University Health Network, Toronto
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Responsible Party: Stryker Neurovascular
ClinicalTrials.gov Identifier: NCT04195568    
Other Study ID Numbers: CDM10001444
First Posted: December 12, 2019    Key Record Dates
Last Update Posted: February 16, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Intracranial Aneurysm
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Calcium Carbonate
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents