Study Evaluating Toro 88 Super Bore Aspiration Catheter for Acute Ischemic Stroke

Официальное название

Open-Label, Single-Arm Study Evaluating Toro 88 Super Bore Aspiration Catheter Safety and Efficacy in Mechanical Thrombectomy for Acute Ischemic Stroke in France

Обзор

The goal of this pilot study is to evaluate the safety and efficacy of the Toro 88 Super Bore Aspiration Catheter in acute ischemic stroke patients.

Подробное описание

This is a prospective, open-label, single-arm, single-center clinical investigation evaluating the safety and efficacy of the Toro 88 Super Bore Aspiration Catheter in mechanical thrombectomy for acute ischemic stroke. The study is being conducted at the Hôpital Fondation Adolphe de Rothschild in France.

Вмешательства

• Устройство Toro 88 Super Bore Aspiration Catheter
  The Toro 88 Super Bore Aspiration Catheter is a neurovascular device designed for clot aspiration during mechanical thrombectomy procedures.

Первичные конечные точки

• Incidence of adverse events that may be associated with the use of the experimental device at 24-36h [Срок оценки: From start of procedure to 24-36 hours post-procedure]

Вторичные конечные точки (10)

• eTICI score ≥ 2b50 after a maximum of 3 passages with the experimental device [Срок оценки: Immediately after final device pass (intra-procedural)]
• Lesion site reached according to the operator [Срок оценки: Intra-procedural]
• eTICI score ≥ 2c after the first pass with the experimental device [Срок оценки: Immediately after first device pass (intra-procedural)]
• eTICI score ≥ 2b67 after the first pass with the experimental device [Срок оценки: Immediately after first device pass (intra-procedural)]
• Symptomatic intracranial haemorrhage [Срок оценки: 22 to 36 hours after reperfusion]
• All adverse events [Срок оценки: From procedure to 90 days post-procedure]
• NIHSS score [Срок оценки: At discharge and at 90 days post-procedure]
• All serious adverse events [Срок оценки: From procedure to 90 days post-procedure]
• All-cause death [Срок оценки: From procedure to 90 days post-procedure]
• Modified Rankin Score (mRS) ≤ 2 [Срок оценки: At 90 days post-procedure]

Критерии участия

Критерии включения

• Patients aged ≥ 18 and ≤ 90 years at the time of consent
• Presenting with an acute ischaemic stroke for which symptoms (or last time seen as normal) are < 24h
• With occlusion of the ICA / the M1 segment of the MCA / a vertebral artery diameter ≥3.5mm / the basilar artery, defined by eTICI≤1
• Requiring endovascular treatment (mechanical thrombectomy) with or without intravenous thrombolysis
• For whom the experimental device is the first-line treatment
• Without pre-existing disability (mRS ≤3 and 6≤ NIHSS ≤30 before stroke)
• Informed consent signed :

• By the patient
• Or consent by a family member/trusted support person if the patient's condition does not allow them to express their consent in writing (L1111-6)

Критерии исключения

• Arterial dissection
• Suspicion of vasculitis
• Suspected intracranial stenosis near the occlusion site
• Concomitant intracranial haemorrhage
• Known coagulation disorder
• Known coagulopathy
• Known platelet count <50,000/μL
• Significant mass effect with midline shift
• Suspicion or evidence of aortic dissection, septic embolus, or bacterial endocarditis
• INR ≥ 3.0
• APTT ≥ 2 times normal
• Systolic blood pressure > 185 mmHg and/or diastolic blood pressure < 110 mmHg
• Blood glucose < 50 mg/dL or >400 mg/dL according to the last measurement taken before the procedure
• Known allergy to contrast media
• Occluded arteries in more than one large vascular territory (at least two of the left and right internal carotid arteries or the territory of a carotid artery and an artery of the vertebrobasilar system).
• Pregnant or breast-feeding women (urine or serum pregnancy test negative at inclusion).
• Adults under legal protection (L1121-8)
• Persons deprived of their liberty by judicial or administrative decision, persons under psychiatric care under articles L3212-1 and L3123-1 and persons admitted to a health or social establishment for purposes other than research (L1121-6).
• Participation in other interventional clinical research

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

Франция · 1 центр

• Hôpital Fondation Adolphe de Rothschild — Paris

Идентификаторы

NCT: NCT07089355 · P_RBC_2025_1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗