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Clinical Trial Details — Status: Active, not recruiting

Administrative data

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

Study information

Verified date May 2024
Source Stryker Neurovascular
Contact n/a
Is FDA regulated No
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
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Recruiting NCT05029947 - Setting Benchmarks for Microsurgical Clipping of Unruptured Intracranial Aneurysms
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Completed NCT02354300 - Transcranial Doppler Ultrasound Monitoring During Flow-Diverter Embolization N/A