Aneurysm, Aneurysm, Intracranial
Conditions
Keywords
Saccular Aneurysm, Fusiform Aneurysm, Unruptured Aneurysm, Flow Diverter
Brief summary
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.
Detailed description
The Surpass Elite with Guardian Flow Diverter System is indicated for use in the endovascular treatment of adults (age 18 or above) with unruptured wide-neck saccular or fusiform intracranial aneurysms arising from a parent vessel with a diameter ≥ 3.0 millimeters (mm) and ≤ 6.0 mm and located on the ICA or its branches.
Interventions
DEVICESurpass Elite with Guardian Flow Diverter System
The Surpass Elite with Guardian Flow Diverter System is indicated for use in the endovascular treatment of adults (age 18 or above) with unruptured wide-neck saccular or fusiform intracranial aneurysms arising from a parent vessel with a diameter ≥ 3.0 millimeter (mm) and ≤ 6.0 mm and located on the Internal Carotid Artery (ICA) or its branches.
Sponsors
Stryker Neurovascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age is ≥18 and ≤80 years at the time of consent 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 wide neck (wide neck typically defined as neck width ≥ 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 mm 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.
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 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 or proper deployment of the trial device to the target aneurysm 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 after the index procedure 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 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 conditions such as dementia or psychiatric problems, active substance abuse, or history of non-compliance with medical advice, as determined by the investigator 23. Pregnant or breast- feeding women or women who wish to become pregnant during the length of trial participation 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary safety endpoint: Number of subjects with neurologic death or major ipsilateral stroke through 12 months as adjudicated by an independent Clinical Events Committee (CEC). | 12 month ± 3 months | Neurological death defined as stroke-related death and related to the vascular territory associated with target aneurysm treatment. Major ipsilateral stroke defined as a stroke with an increase in National Institutes of Health Stroke Scale (NIHSS) score ≥ 4 points persisting ≥ 24 hours and related to the vascular territory associated with target aneurysm treatment. |
| The primary efficacy endpoint: Number of subjects with 100% occlusion of the target aneurysm without significant parent artery stenosis, and with no target aneurysm retreatment through the 12-month follow-up visit timepoint. | 12 month ± 3 months | The primary efficacy endpoint is a composite of 100% occlusion (Raymond-Roy Class 1, complete occlusion) of the target aneurysm without significant parent artery stenosis (significant parent artery stenosis is defined as \> 50% stenosis, per independent core lab assessment of digital subtraction angiography \[DSA\] images acquired at 12 months \[± 90 days\] post-procedure), and with no target aneurysm retreatment through the 12-month follow-up visit timepoint. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Safety Endpoint #1: Number of subjects with neurological death or disabling stroke as adjudicated by an independent Clinical Events Committee (CEC). | 12 month ± 3 months, 36 month ± 3 months, and 60 month ± 3 months if FDA grants Premarket approval (PMA) of the Surpass Elite with Guardian Flow Diverter System | Neurological death defined as stroke-related death and related to the vascular territory associated with target aneurysm treatment. Disabling stroke defined as stroke related to the vascular territory associated with target aneurysm treatment that results in a modified Rankin Score (mRS) score ≥ 3, as assessed by an independent qualified (certified or with documented qualification per institution standard of care) assessor at a minimum of 90 days post stroke event. The number of subjects with neurological deaths or disabling strokes as adjudicated by an independent Clinical Events Committee (CEC) will be analyzed. |
| Secondary Safety Endpoint #2: Number of subjects with stroke related to the vascular territory associated with target aneurysm treatment as adjudicated by an independent Clinical Events Committee (CEC). | 12 month ± 3 months, 36 month ± 3 months, and 60 month ± 3 months if FDA grants Premarket approval (PMA) of the Surpass Elite with Guardian Flow Diverter System | The number of subjects with strokes related to the vascular territory associated with target aneurysm treatment as adjudicated by an independent Clinical Events Committee (CEC) will be analyzed. |
| Secondary Safety Endpoint #3: Number of subjects with combined stroke and transient ischemic attack (TIA) events as adjudicated by a CEC | 12 month ± 3 months, 36 month ± 3 months, and 60 month ± 3 months if FDA grants Premarket approval (PMA) of the Surpass Elite with Guardian Flow Diverter System | The number of subjects with combined stroke and transient ischemic attack (TIA) events as adjudicated by an independent Clinical Events Committee (CEC) will be analyzed |
| Secondary Efficacy Endpoint #1: Number of subjects with 100% occlusion (Raymond-Roy Class 1, complete occlusion) of the target aneurysm at follow-up visits | 12 month ± 3 months, 36 month ± 3 months, and 60 month ± 3 months if FDA grants Premarket approval (PMA) of the Surpass Elite with Guardian Flow Diverter System | The number of subjects with 100% occlusion (Raymond-Roy Class 1, complete occlusion) of the target aneurysm at follow-up visits, per independent core lab assessment of DSA images will be analyzed |
| Secondary Efficacy Endpoint #2: Number of subjects with 100% occlusion of the target aneurysm at follow-up visits, per independent core lab assessment of any images (including but not limited to MRA and CTA) | 12 month ± 3 months, 36 month ± 3 months, and 60 month ± 3 months if FDA grants Premarket approval (PMA) of the Surpass Elite with Guardian Flow Diverter System | 100% occlusion (Raymond-Roy Class 1, complete occlusion) of the target aneurysm at follow-up visits, per independent core lab assessment of any images (including but not limited to MRA and CTA) |
| Secondary Efficacy Endpoint #3: Number of subjects with significant (> 50% stenosis) parent artery stenosis as determined by independent core lab post-procedure | 12 month ± 3 months, 36 month ± 3 months, and 60 month ± 3 months if FDA grants Premarket approval (PMA) of the Surpass Elite with Guardian Flow Diverter System | The number of subjects with significant (\> 50% stenosis) parent artery stenosis as determined by independent core lab post-procedure will be analyzed |
| Secondary Efficacy Endpoint #4: Number of subjects with target aneurysm retreatment. | 12 month ± 3 months, 36 month ± 3 months, and 60 month ± 3 months if FDA grants Premarket approval (PMA) of the Surpass Elite with Guardian Flow Diverter System | The number of subjects with target aneurysm retreatment will be analyzed |
Countries
United States
Contacts
CONTACTStacy Phung
CONTACTJohn Strohmeyer
Outcome results
None listed