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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Surpass 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.

Первичные конечные точки

• 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). [Срок оценки: 12 month ± 3 months]
• 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. [Срок оценки: 12 month ± 3 months]

Вторичные конечные точки (7)

• Secondary Safety Endpoint #1: Number of subjects with neurological death or disabling stroke as adjudicated by an independent Clinical Events Committee (CEC). [Срок оценки: 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]
• 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). [Срок оценки: 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]
• Secondary Safety Endpoint #3: Number of subjects with combined stroke and transient ischemic attack (TIA) events as adjudicated by a CEC [Срок оценки: 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]
• Secondary Efficacy Endpoint #1: Number of subjects with 100% occlusion (Raymond-Roy Class 1, complete occlusion) of the target aneurysm at follow-up visits [Срок оценки: 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]
• 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) [Срок оценки: 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]
• Secondary Efficacy Endpoint #3: Number of subjects with significant (> 50% stenosis) parent artery stenosis as determined by independent core lab post-procedure [Срок оценки: 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]
• Secondary Efficacy Endpoint #4: Number of subjects with target aneurysm retreatment. [Срок оценки: 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]

Критерии участия

Критерии включения

• Age is ≥18 and ≤80 years at the time of consent
• Has a single unruptured target intracranial aneurysm (IA) of any size with the following characteristics:

• Is located on the internal carotid artery or its branches
• 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
• Aneurysm is either saccular or fusiform in nature
• Has a parent vessel diameter ≥ 3.0 mm to ≤ 6.0 mm at the largest diameter
• 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.

Критерии исключения

• Has an extradural target aneurysm
• Has a target aneurysm in the posterior circulation
• 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)
• Has a true bifurcation aneurysm, defined as an aneurysm (saccular or non-saccular) located at a point of vessel bifurcation
• 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
• Received previous treatment for the target aneurysm or parent artery where it would interfere with the placement or proper apposition of the device
• 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
• Has a known severe allergy to nickel, chromium cobalt, tungsten, or platinum
• Patients with heparin hypersensitivity, including patients with a previous incident of Heparin-Induced Thrombocytopenia (HIT).
• Modified Rankin Score (mRS) assessment is ≥ 3 at pre-procedure exam
• Presence of unstable neurological deficit (i.e., worsening of clinical condition in the last 30 days prior to the index procedure)
• Subarachnoid hemorrhage occurred within 30 days prior to the index procedure
• 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
• Has more than one intracranial aneurysm (IA) that requires treatment within 12 months after the index procedure
• Received previous intracranial implant associated with the symptomatic or vascular distribution within the past 84 days prior to treatment date
• Chronic anticoagulation therapy is ongoing or known coagulopathy exists
• Has atrial fibrillation with or without pacemaker.
• 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
• Has acute life-threatening illness (e.g., acute kidney or heart failure) other than the neurological disease to be treated in this trial
• Evidence of active infection at the time of treatment
• Life expectancy is less than 5 years due to other illness or condition (in addition to an intracranial aneurysm)
• 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
• Pregnant or breast- feeding women or women who wish to become pregnant during the length of trial participation
• Presence of intracranial mass (tumor, except meningioma, abscess, or other infection), non-treated arteriovenous malformation (AVM) in the territory of the target aneurysm
• Enrollment in another study involving an investigational product that could confound the outcomes of this trial

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 10 центров

• Carondelet St. Joseph's Hospital — Tucson
• University of California Davis Health — Davis
• Stanford University School of Medicine — Palo Alto
• Lyerly Neurosurgery, an Affiliate of Baptist — Jacksonville
• University of Kansas Medical Center — Kansas City
• Lahey Hospital and Medical Center — Burlington
• Mount Sinai Health System — New York
• Stony Brook University Hospital — Stony Brook
• … и ещё 2 центра

Идентификаторы

NCT: NCT06872684 · CDM10001836

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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