Trial Review

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04195568




Registration number
NCT04195568
Ethics application status
Date submitted
4/12/2019
Date registered
12/12/2019
Date last updated
24/05/2024

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
N/A
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
249
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
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Iowa
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Maine
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Oregon
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
Tennessee
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Utah
Country [21] 0 0
United States of America
State/province [21] 0 0
Virginia
Country [22] 0 0
Canada
State/province [22] 0 0
Ontario

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

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT04195568
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04195568