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

Aneurysm, Intracranial Clinical Trial

— EVOLVE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04195568
• Other study ID #: CDM10001444
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 7, 2020
• Est. completion date: September 13, 2028

Study information

• Verified date: November 2023
• Source: Stryker Neurovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 249
• Est. completion date: September 13, 2028
• Est. primary completion date: September 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aneurysm, Intracranial
• Intracranial Aneurysm

Intervention

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.

Locations

Country	Name	City	State
Australia	Liverpool Hospital	Liverpool	New South Wales
Australia	Sir Charles Gairdner Hospital	Nedlands	Perth
Australia	Gold Coast Hospital & Health Service/ Gold Coast University Hospital	Southport	Queensland
Canada	St. Michael's Hospital - Toronto	Toronto	Ontario
Canada	University Health Network/ Toronto Western Hospital	Toronto	Ontario
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	University of Buffalo	Buffalo	New York
United States	Lahey Clinic	Burlington	Massachusetts
United States	Cleveland Clinic	Cleveland	Ohio
United States	University of Texas Medical Branch	Galveston	Texas
United States	Spectrum Health	Grand Rapids	Michigan
United States	Valley Baptist Health System, Harlingen	Harlingen	Texas
United States	Indiana University	Indianapolis	Indiana
United States	University of Iowa	Iowa City	Iowa
United States	Lyerly Baptist, Inc./Baptist Medical Center - Jacksonville/Lyerly Neurosurgery	Jacksonville	Florida
United States	Mayo Clinic Florida	Jacksonville	Florida
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Baptist Healthcare System, Inc./Baptist Health	Lexington	Kentucky
United States	University of California, Los Angeles	Los Angeles	California
United States	Semmes Murphey Clinic/ University of Tennessee Health Sciences Center	Memphis	Tennessee
United States	Baptist Hospital of Miami	Miami	Florida
United States	Robert Wood Johnson University Medical Center	New Brunswick	New Jersey
United States	Yale School of Medicine	New Haven	Connecticut
United States	ICAHN School of Medicine at Mount Sinai	New York	New York
United States	University of Massachusetts	North Worcester	Massachusetts
United States	Advocate Lutheran General Hospital	Park Ridge	Illinois
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	DIGNITY HEALTH/ Barrow Neurological Institute	Phoenix	Arizona
United States	Maine Medical Center	Portland	Maine
United States	Oregon Health & Science University	Portland	Oregon
United States	Virginia Commonwealth University	Richmond	Virginia
United States	University of Utah	Salt Lake City	Utah
United States	Stony Brook	Stony Brook	New York
United States	Tallahassee Neurological Clinic	Tallahassee	Florida
United States	St. Joseph's Hospital	Tucson	Arizona
United States	Geisinger Clinic	Wilkes-Barre	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Neurovascular

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Effectiveness Endpoint	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.	12 months (± 3 months) post procedure
Primary	Primary Safety Endpoint	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).	12 Months (± 3 months) post procedure
Secondary	Secondary Safety Endpoints	The secondary safety endpoints will be evaluated throughout the study, and are as follows: Neurological death or major ipsilateral stroke as adjudicated by an independent Clinical Events Committee.; Stroke in the treated vascular territory as adjudicated by a Clinical Events Committee	3 Year Follow-Up