Набор скоро начнётся NCT07376447

Evaluation of iNstroke Aspiration Catheters for Thrombectomy: a Multi-center Prospective Study

Без фазы С лечением Acute Ischemic Stroke

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Thromboaspiration catheter.
Кому может быть актуально: Состояния в реестре: Acute Ischemic Stroke. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция, Германия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Confirmation of the Performance and Safety of the iNstroke 6F and 4F Thromboaspiration Catheter for the Treatment of Acute Ischemic Stroke

Обзор

Prospective, single-arm, multi-center study to confirm the performance and safety of the iNstroke 6F and 4F thromboaspiration catheter for the treatment of acute ischemic stroke

Подробное описание

This clinical investigation has been designed to generate further data demonstrating the safety and effectiveness of the iNstroke device as well as of the thrombectomy process for the treatment of large and medium vessel occlusions.

Вмешательства

Устройство Thromboaspiration catheter
Patients to undergo thromboaspiration with iNstroke 6F and/or 4F

Первичные конечные точки

Recanalization Rate [Срок оценки: Intra-procedure]

Критерии участия

Критерии включения

Patients ≥ 18 years of age.
Able to be treated (i.e., defined by arterial puncture time) within 24 hours of symptom onset or last time seen well (LTSW).
Demonstrated occlusion in a large and/or medium vessel (carotid T, M1, proximal M2, M2-M3, A1, A2, A3, basilar artery, P1, P2, P3).
Baseline NIHSS score ≥6 assessed before the procedure.
Pre-morbid \[xB13.1\]stroke baseline mRS ≤ 2.
Subjects with an ASPECTS ≥ 6.
Informed consent signed by the subject or their representative, or notice of information, as per regulatory requirements, to collect the subject's data.
As applicable by French laws, the subject is affiliated to a health social security regimen or equivalent (only to be answered by French sites).

Критерии исключения

Severe comorbidity and/or shortened life expectancy that will likely prevent improvement or follow up or that will render the procedure unlikely to benefit the patient.
Severe allergy to contrast media.
As applicable by French laws: breastfeeding women, persons deprived of their liberty by a judicial or administrative decision, or persons of full age who are the subject of a legal protection measure.
Patients with intracranial atherosclerotic occlusive disease or extra- or intracranial dissection.
Multiple Intracranial Occlusions
Known medical history of thrombocytopenia (Platelets <100,000).
Presence of intracerebral hemorrhage.
Significant mass effect and/or midline shift.
Evidence of intracranial tumor (except small meningioma).
Intracranial stenosis proximal to the occlusion.
Severe sustained hypertension (systolic pressure >185 mm Hg or diastolic pressure >110 mm Hg). Note: If blood pressure can be successfully reduced and maintained at an acceptable level by administering the medication recommended by the ESO (European Stroke Organisation) in its guidelines (also IV infusion of antihypertensives), the patient may be included.
Known or suspected cerebral vasculitis.
Known renal insufficiency with creatinine ≥3 mg/dl or Glomerular Filtration Rate (GFR) <30 mL/min.
Current participation in an interventional drug or device study that may confound the results of this study.

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

Здоровые добровольцы: Нет