Study to Evaluate the TUBE Device Ability to Treat Unruptured, Wide-neck or Fusiform Aneurysms

Официальное название

A Prospective, Single-Arm, Multicenter, Feasibility Trial to Evaluate the Safety and Performance of the TUBE Device in the Endovascular Treatment of Unruptured, Wide-Neck or Fusiform Intracranial Aneurysms

Обзор

To assess the safety and performance of the TUBE device in the endovascular treatment of unruptured, wide-neck or fusiform intracranial aneurysms located on the internal carotid artery (ICA) or its branches

Подробное описание

This is a prospective, single-arm, multicenter study designed to assess the safety and performance of the TUBE device in the endovascular treatment of unruptured, saccular wide-neck (neck width ≥ 4 mm or dome-to-neck ratio \< 2) or fusiform intracranial aneurysms arising from a parent vessel with a diameter ≥ 2.0 mm and ≤ 5.0 mm and located on the ICA or its branches.

Up to 20 eligible patients who present for flow diverter placement, provide informed consent, meet all inclusion crite-ria, and not meet any exclusion criteria will receive treatment with the TUBE device. All participants will be followed for 1 year. Post-procedure, imaging will be repeated at the Day 30, Month 3, 6, and 12 visits.

Вмешательства

• Устройство TUBE Flow Diverter
  TUBE Device

Первичные конечные точки

• Neurologic death, or disabling stroke [Срок оценки: At 12 months]
• Primary Performance Outcome [Срок оценки: At 12 months post-procedure]

Вторичные конечные точки (1)

• Performance Outcome [Срок оценки: 1 month, 3 months, and 6 months post-procedure respectively]

Критерии участия

Критерии включения

• Has a single unruptured target intracranial aneurysm (IA) with the following characteristics:

• Is located on the internal carotid artery or its branch-es.
• Has a neck ≥ 4 mm, dome to neck ratio < 2.0, or no discernible neck
• Aneurysm diameter ≤ 35 mm (saccular or fusiform configuration)
• Has a parent vessel diameter ≥ 2.0 mm and ≤ 5.0 mm at both the proximal and distal segments where the implant will be placed.
• Has multiple increased risk factors for intracranial aneurysm rupture, including but not limited to, aneurysm morphology, smoking, hypertension, diabetes, age, prior and/or family history of aneurysm 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 patient's expected lifetime if left untreated.
• The patient is able and willing to provide written in-formed consent.

Критерии исключения

Participants are not eligible for the study if ANY of the following criteria are present:

• Has an extradural 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 study)
• Has a true bifurcation aneurysm, defined as an aneurysm (saccular or non-saccular) located at a point of vessel bifurcation
• Target aneurysm is unsuitable for flow diverter treatment
• 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
• Received previous treatment of the target aneurysm or parent artery where it would interfere with the placement or proper apposition of the device
• Has a medical contraindication to study or procedure related antiplatelet medications (aspirin, clopidogrel/ Plavix, prasugrel, ticagrelor, and heparin), local or general anesthesia, or life-threatening allergy to contrast dye
• Non-responders to prasugrel as determined by the P2Y12 assay ("VerifyNow" system)
• Has a known severe allergy to nickel titanium, stainless steel (304SS) tantalum, or platinum.
• Modified Rankin Score assessment is ≥ 3 at pre-procedure exam
• Presence of unstable neurological deficit (i.e., worsening of clinical condition in the last 30 days)
• Subarachnoid hemorrhage occurred within 30 days prior to enrollment
• Major surgery (including previous intracranial implant) occurred within previous 30 days or is planned in the next 120 days after enrollment date
• Has more than one intracranial aneurysm that requires treatment within 12 months
• Received previous intracranial implant associated with the symptomatic or vascular distribution within the past 12 weeks prior to treatment date
• Chronic anticoagulation therapy is ongoing or known coagulopathy exists
• Has other known serious concurrent medical conditions such as heart disease (e.g., 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
• Has acute life-threatening illness other than the neurological disease (e.g., acute kidney or heart failure) to be treated in this trial
• Life expectancy is less than 5 years due to other illness or condition (in addition to an intracranial aneurysm)
• Unable to complete study follow up due to dementia or psychiatric problem, substance abuse, or history of noncompliance with medical advice
• Pregnancy at time of enrollment
• Presence of intracranial mass (tumor, except meningioma, abscess, or other infection), non-treated arteriovenous malformation (AVM) in the territory of the target aneurysm
• Evidence of active infection at the time of treatment
• Enrollment in another trial 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

Бразилия · 3 центра

• Hospital Geral de Fortaleza — Fortaleza
• Instituto Estadual do Cérebro Paulo Niemeyer — Rio de Janeiro
• Hospital das Clínicas da Faculdade de Medicina da USP — São Paulo

Идентификаторы

NCT: NCT07079956 · NV01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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