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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04195568
Recruitment Status : Recruiting
First Posted : December 12, 2019
Last Update Posted : September 16, 2022
Sponsor:
Information provided by (Responsible Party):
Stryker Neurovascular

Tracking Information
First Submitted Date  ICMJE December 4, 2019
First Posted Date  ICMJE December 12, 2019
Last Update Posted Date September 16, 2022
Actual Study Start Date  ICMJE July 7, 2020
Estimated Primary Completion Date July 28, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 9, 2019)
  • 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.
  • 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2019)		 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Safety and Effectiveness of Stryker Surpass Evolve™ Flow Diverter System
Official Title  ICMJE EndoVascular Treatment Of Wide-Neck Aneurysms, an EvaLuation of Safety and EffectiVeness of Stryker Surpass Evolve™ Flow Diverter System
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
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Aneurysm, Intracranial
Intervention  ICMJE 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.
Study Arms  ICMJE 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).
Intervention: Device: Surpass Evolve Flow Diverter System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 9, 2019)		 235
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2025
Estimated Primary Completion Date July 28, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 (cICA Type IV), stenosis (>70%), or morphology that would preclude safe endovascular access to the target aneurysm necessary for treatment with the study device
  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 life-threatening 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 (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
  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
  23. Evidence of active infection at the time of treatment
  24. Enrollment in another trial involving an investigational product that could confound the outcomes of this trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sabrina Louie, MPH 949-419-5605 sabrina.louie@stryker.com
Contact: Alice Lin 408-326-9689 alice.lin@stryker.com
Listed Location Countries  ICMJE Australia,   Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04195568
Other Study ID Numbers  ICMJE CDM10001444
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Stryker Neurovascular
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Stryker Neurovascular
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Adam S Arthur, MD Semmes Murphy Clinic
Principal Investigator: Vitor M Pereira, MD University Health Network, Toronto
PRS Account Stryker Neurovascular
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP