RECRUITING

Safety and Efficacy of Endovascular Treatment of Intracranial Aneurysms With Surpass Elite With GUARDian Flow Diverter (GUARD)

Conditions

Aneurysm Aneurysm, Intracranial Saccular Aneurysm Fusiform Aneurysm Unruptured Aneurysm Flow Diverter

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The objective of the Safety and Efficacy of Endovascular Treatment of Intracranial Aneurysms with Surpass Elite with GUARDian Flow Diverter (GUARD) trial is to evaluate the safety and efficacy of the Surpass Elite with Guardian Flow Diverter System (FDS) in the treatment of unruptured, wide-neck saccular or fusiform, intracranial aneurysms (IAs) located on the internal carotid artery (ICA) or its branches.

Official Title

Safety and Efficacy of Endovascular Treatment of Intracranial Aneurysms With Surpass Elite With GUARDian Flow Diverter

Quick Facts

Study Start:2025-06-20

Study Completion:2028-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06872684

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age is ≥18 to ≤80 years 2. Has a single unruptured target intracranial aneurysm (IA) of any size with the following characteristics: 1. Is located on the internal carotid artery or its branches 2. Has a neck ≥ 4 millimeter (mm), or dome to neck ratio ≤ 2.0, or no discernible neck 3. Aneurysm is either saccular or fusiform in nature 3. Has a parent vessel diameter ≥ 3.0 to ≤ 6.0 mm at the largest diameter 4. There is documented risk-benefit of endovascular treatment that outweighs the risks of intracranial aneurysm rupture during the subject's expected lifetime if left untreated.	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 trial) 4. Has a true bifurcation aneurysm, defined as an aneurysm (saccular or non-saccular) located at a point of vessel bifurcation 5. Has vessel characteristics, such as severe tortuosity (cavernous Internal Carotid Artery (cICA) Type IV1), stenosis (\>70%), or morphology that would preclude safe endovascular access to the target aneurysm necessary for treatment with the trial device 6. Received previous treatment for the target aneurysm or parent artery where it would interfere with the placement or proper apposition of the device 7. Has a medical contraindication to trial or procedure related antiplatelet medications (aspirin, clopidogrel/Plavix, ticagrelor, and heparin), local or general anesthesia, or life-threatening allergy to contrast dye 8. Has a known severe allergy to nickel, chromium cobalt, tungsten, or platinum 9. Patients with heparin hypersensitivity, including patients with a previous incident of Heparin-Induced Thrombocytopenia (HIT). 10. Modified Rankin Score (mRS) assessment is ≥ 3 at pre-procedure exam 11. Presence of unstable neurological deficit (i.e., worsening of clinical condition in the last 30 days prior to the index procedure) 12. Subarachnoid hemorrhage occurred within 30 days prior to the index procedure 13. Major surgery (including previous intracranial implant) either occurred within 30 days prior to the index procedure date or is planned to occur within 120 days following the index procedure date 14. Has more than one intracranial aneurysm (IA) that requires treatment within 12 months 15. Received previous intracranial implant associated with the symptomatic or vascular distribution within the past 84 days prior to treatment date 16. Chronic anticoagulation therapy is ongoing or known coagulopathy exists 17. Has atrial fibrillation with or without pacemaker. 18. Has other known serious concurrent medical conditions such as heart cardiovascular disease (including recent myocardial infarction \[\<12 weeks\], symptomatic congestive heart failure, or carotid stenosis), kidney failure \[\>2.0 mg/dl serum creatinine\], pulmonary disease, uncontrolled diabetes, progressive neurologic disorders, terminal cancer, vasculitis, high risk of ischemic stroke or recent stroke 19. Has acute life-threatening illness (e.g., acute kidney or heart failure) other than the neurological disease to be treated in this trial 20. Evidence of active infection at the time of treatment 21. Life expectancy is less than 5 years due to other illness or condition (in addition to an intracranial aneurysm) 22. Unable to comply with the trial follow up requirements due to dementia or psychiatric problem, substance abuse, or history of non-compliance with medical advice 23. Pregnancy at time of enrollment 24. Presence of intracranial mass (tumor, except meningioma, abscess, or other infection), non-treated arteriovenous malformation (AVM) in the territory of the target aneurysm 25. Enrollment in another study involving an investigational product that could confound the outcomes of this trial

Inclusion Criteria

Exclusion Criteria

1. Age is ≥18 to ≤80 years
2. Has a single unruptured target intracranial aneurysm (IA) of any size with the following characteristics:
1. Is located on the internal carotid artery or its branches
2. Has a neck ≥ 4 millimeter (mm), or dome to neck ratio ≤ 2.0, or no discernible neck
3. Aneurysm is either saccular or fusiform in nature
3. Has a parent vessel diameter ≥ 3.0 to ≤ 6.0 mm at the largest diameter
4. There is documented risk-benefit of endovascular treatment that outweighs the risks of intracranial aneurysm rupture during the subject's expected lifetime if left untreated.

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 trial)
4. Has a true bifurcation aneurysm, defined as an aneurysm (saccular or non-saccular) located at a point of vessel bifurcation
5. Has vessel characteristics, such as severe tortuosity (cavernous Internal Carotid Artery (cICA) Type IV1), stenosis (\>70%), or morphology that would preclude safe endovascular access to the target aneurysm necessary for treatment with the trial device
6. Received previous treatment for the target aneurysm or parent artery where it would interfere with the placement or proper apposition of the device
7. Has a medical contraindication to trial or procedure related antiplatelet medications (aspirin, clopidogrel/Plavix, ticagrelor, and heparin), local or general anesthesia, or life-threatening allergy to contrast dye
8. Has a known severe allergy to nickel, chromium cobalt, tungsten, or platinum
9. Patients with heparin hypersensitivity, including patients with a previous incident of Heparin-Induced Thrombocytopenia (HIT).
10. Modified Rankin Score (mRS) assessment is ≥ 3 at pre-procedure exam
11. Presence of unstable neurological deficit (i.e., worsening of clinical condition in the last 30 days prior to the index procedure)
12. Subarachnoid hemorrhage occurred within 30 days prior to the index procedure
13. Major surgery (including previous intracranial implant) either occurred within 30 days prior to the index procedure date or is planned to occur within 120 days following the index procedure date
14. Has more than one intracranial aneurysm (IA) that requires treatment within 12 months
15. Received previous intracranial implant associated with the symptomatic or vascular distribution within the past 84 days prior to treatment date
16. Chronic anticoagulation therapy is ongoing or known coagulopathy exists
17. Has atrial fibrillation with or without pacemaker.
18. Has other known serious concurrent medical conditions such as heart cardiovascular disease (including recent myocardial infarction \[\<12 weeks\], symptomatic congestive heart failure, or carotid stenosis), kidney failure \[\>2.0 mg/dl serum creatinine\], pulmonary disease, uncontrolled diabetes, progressive neurologic disorders, terminal cancer, vasculitis, high risk of ischemic stroke or recent stroke
19. Has acute life-threatening illness (e.g., acute kidney or heart failure) other than the neurological disease to be treated in this trial
20. Evidence of active infection at the time of treatment
21. Life expectancy is less than 5 years due to other illness or condition (in addition to an intracranial aneurysm)
22. Unable to comply with the trial follow up requirements due to dementia or psychiatric problem, substance abuse, or history of non-compliance with medical advice
23. Pregnancy at time of enrollment
24. Presence of intracranial mass (tumor, except meningioma, abscess, or other infection), non-treated arteriovenous malformation (AVM) in the territory of the target aneurysm
25. Enrollment in another study involving an investigational product that could confound the outcomes of this trial

Contacts and Locations

Study Contact

Sabrina Louie, MPH

CONTACT

(949) 419-5605

sabrina.louie@stryker.com

Darren LaCour, Jr.

CONTACT

darren.lacour@stryker.com

Principal Investigator

Alexander Coon, MD

PRINCIPAL_INVESTIGATOR

Carondelet at St. Joesphs

David Fiorella, MD

PRINCIPAL_INVESTIGATOR

Stony Brook University

Study Locations (Sites)

Carondelet St. Joseph's Hospital

Tucson, Arizona, 85711

United States

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01803

United States

Collaborators and Investigators

Sponsor: Stryker Neurovascular

Alexander Coon, MD, PRINCIPAL_INVESTIGATOR, Carondelet at St. Joesphs
David Fiorella, MD, PRINCIPAL_INVESTIGATOR, Stony Brook University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-20

Study Completion Date2028-03-31

Study Record Updates

Study Start Date2025-06-20

Study Completion Date2028-03-31

Terms related to this study

Keywords Provided by Researchers

Saccular Aneurysm
Fusiform Aneurysm
Unruptured Aneurysm
Flow Diverter

Additional Relevant MeSH Terms

Aneurysm
Aneurysm, Intracranial