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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04195568




Registration number
NCT04195568
Ethics application status
Date submitted
4/12/2019
Date registered
12/12/2019

Titles & IDs
Public title
Evaluation of Safety and Effectiveness of Stryker Surpass Evolve™ Flow Diverter System
Scientific title
EndoVascular Treatment of Wide-Neck Aneurysms, an EvaLuation of Safety and EffectiVeness of Stryker Surpass Evolve™ Flow Diverter System
Secondary ID [1] 0 0
CDM10001444
Universal Trial Number (UTN)
Trial acronym
EVOLVE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aneurysm, Intracranial 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Surpass Evolve Flow Diverter System

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).


Treatment: Devices: 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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Effectiveness Endpoint
Timepoint [1] 0 0
12 months (± 3 months) post procedure
Primary outcome [2] 0 0
Primary Safety Endpoint
Timepoint [2] 0 0
12 Months (± 3 months) post procedure
Secondary outcome [1] 0 0
Secondary Safety Endpoints
Timepoint [1] 0 0
3 Year Follow-Up

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/07/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
13/09/2028
Actual
Sample size
Target
Accrual to date
Final
248
Recruitment in Australia
Recruitment state(s)
NSW,PerthQLD
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [3] 0 0
Gold Coast Hospital & Health Service/ Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 0 0
NSW 2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2170 - Nedlands
Recruitment postcode(s) [3] 0 0
4215 - Southport
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Maine
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Oregon
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Utah
Country [20] 0 0
United States of America
State/province [20] 0 0
Virginia
Country [21] 0 0
Canada
State/province [21] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Stryker Neurovascular
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Adam S Arthur, MD
Address 0 0
Semmes Murphy Clinic
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04195568