REVascularization In Large VEssel Occlusion for Acute Ischemic Stroke

Обзор

The objective of this study is to evaluate the safety and effectiveness of the SOFIA Flow 88 Aspiration Catheter for treatment of acute ischemic stroke.

Подробное описание

The investigation is a prospective, single-arm, multi-center clinical study. The study will be conducted in up to 40 investigational sites in the US, Canada, and Europe. This study will enroll up to 200 subjects, with a maximum enrollment of 30 subjects per site.

Вмешательства

• Устройство SOFIA Flow 88 Aspiration Catheter
  The investigational device is the SOFIA Flow 88 Aspiration Catheter with the MV Flow Aspiration Pump and MicroVention Tubing Kit and is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 segment) within 8 hours of symptom onset.

Первичные конечные точки

• Incidence of all symptomatic intracranial hemorrhage (sICH) [Срок оценки: 24 hours post-procedure]
• Reperfusion success [Срок оценки: During procedure]

Вторичные конечные точки (10)

• Reperfusion success (defined as independent core laboratory adjudicated mTICI/eTICI ≥2b flow) [Срок оценки: During procedure]
• Time from arterial access to achieve mTICI/eTICI ≥2b [Срок оценки: During procedure]
• Incidence of mTICI/eTICI 3 reperfusion [Срок оценки: During procedure]
• Incidence of mTICI/eTICI ≥2c reperfusion [Срок оценки: During procedure]
• Incidence of mTICI/eTICI ≥2b reperfusion achieved with first pass of the SOFIA Flow 88 Aspiration Catheter [Срок оценки: During procedure]
• Incidence of mTICI/eTICI ≥2c reperfusion achieved with first pass of the SOFIA Flow 88 Aspiration Catheter [Срок оценки: During procedure]
• Incidence of functional independence (modified Rankin scale (mRS) ≤2) [Срок оценки: 90-days follow-up]
• Mortality [Срок оценки: 90 days post-procedure]
• Incidence of intracranial hemorrhage (ICH) [Срок оценки: 24 hours post-procedure]
• Incidence of Embolization to New Territory [Срок оценки: During procedure]

Критерии участия

Критерии включения

• Age ≥18 years on the date of consent
• National Institutes of Health Stroke Score (NIHSS) ≥6
• Alberta Stroke Program Early CT Score (ASPECTS) ≥6 assessed within 120 minutes before arterial access, defined by either baseline non-contrast computed tomography (NCCT) or baseline diffusion-weighted magnetic resonance imaging (DW-MRI)
• Angiographically suitable for endovascular intervention and the interventionalist estimates that arterial access can be achieved within 8 hours from time last known well
• Independent status immediately pre-stroke defined as ability to perform all activities of daily living as defined by mRS 0-1
• Large vessel occlusion of the intracranial internal carotid artery (ICA), middle cerebral artery (MCA) M1 segment technically accessible, as assessed during the index procedure, using a SOFIA Flow 88 Aspiration Catheter
• Subject or legally authorized representative (LAR) is willing and able to provide informed consent, as evidenced by signing and dating the IRB-approved informed consent form prior to initiation of any study-specific procedures
• Willing and able to comply with the protocol-specified procedures and assessments

Критерии исключения

• Any intracranial hemorrhage at baseline
• Previous stroke within 90 days
• Female who is pregnant or lactating or has a positive pregnancy test at time of admission
• Arterial occlusive lesion is not technically amenable to recanalization, as assessed during the index procedure, using a SOFIA Flow 88 Aspiration Catheter (e.g., an extracranial carotid lesion prevents access, evidence of carotid dissection)
• Clinical symptoms or non-invasive imaging suggestive of or confirming bilateral stroke or stroke in multiple territories defined as multiple large vessel occlusions (e.g., bilateral proximal MCA occlusions)
• Comorbid illness that would confound the neurological or functional evaluation or is severe enough (e.g., metastatic cancer, severe congestive heart failure) such that life expectancy is <1 year or the 90-day outcome is likely to be determined by the comorbid illness
• Any contraindication to endovascular thrombectomy, such as a known history of severe contrast allergy or absolute contraindication to iodinated contrast
• Participation in another clinical trial involving an investigational mechanical device (subjects may be co-enrolled in a registry study where there is no investigational treatment).

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07216170 · TER-CL-5000

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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