A Pivotal Study Evaluating Safety and Effectiveness of Adaptative Tip Catheter in Patients With Acute Ischemic Stroke

Официальное название

A Prospective, First in Human Pivotal Study to Evaluate the Adaptive Tip Catheter Used to Treat Acute Ischemic Stroke Patients During Mechanical Thrombectomy

Обзор

The purpose of this study is to assess the safety and the effectiveness of the Adaptive Tip Catheter (ATC) used as a first line direct aspiration thrombectomy technique for patients suffering of an acute ischemic stroke.

Вмешательства

• Процедура Adaptive Tip Catheter
  Patients will undergo mechanical thrombectomy using ATC.

Первичные конечные точки

• Third Pass Reperfusion Assessed by Independent Imaging Core Lab [Срок оценки: Intraoperative]

Вторичные конечные точки (6)

• First Pass Reperfusion [Срок оценки: Intraoperative]
• Final Procedural Reperfusion [Срок оценки: Intraoperative]
• Modified Rankin Scale (mRS) Score of 0-2 at 90 days Post-Procedure [Срок оценки: At 90 days post-procedure]
• Vessel Damage [Срок оценки: At 90 days post-procedure]
• All-Cause Mortality [Срок оценки: At 90 days post-procedure]
• Symptomatic Intracranial Hemorrhage (sICH) at 24 hours [Срок оценки: At 24 hours after intervention]

Критерии участия

Критерии включения

• Age greater than or equal to (>=) 18 years, less than or equal to (<=) 90 years, at the time of consent
• Signs and symptoms consistent with the diagnosis of acute ischemic stroke in the anterior circulation that can be treated with endovascular thrombectomy approaches
• Endovascular treatment can be initiated (defined as access puncture) within 24 hours from time last known well
• Baseline National Institutes of Health Stroke Scale (NIHSS) score >= 6
• Baseline Alberta Stroke Program Early CT Score (ASPECTS) >= 3
• A signed and dated Informed Consent Form (ICF) or Investigator Statement for emergency procedure (as allowed according to country regulations and approved by EC) has been obtained

Критерии исключения

• Known pregnancy, as evidenced by positive pregnancy test for women of childbearing potential or breast feeding
• Life expectancy less than (<) 90 days prior to stroke onset
• Known hemorrhagic diathesis disorder, coagulation factor deficiency or oral anticoagulant therapy with known International Normalized Ratio (INR) greater than (>) 3.0
• Clinical symptoms and/or CT/MRI evidence suggestive of bilateral stroke or stroke in multiple vascular territories, defined as occlusions in more than one vessel not downstream from each other (for example, bilateral anterior circulation, anterior/posterior circulation)
• Clinical history, past imaging or clinical judgement suggest that the intracranial occlusion is chronic
• Computed Tomography/ Magnetic Resonance Imaging (CT/MRI) evidence of recent/fresh hemorrhage
• Baseline CT or MRI showing mass effect
• Currently participating in an investigational (drug, device, etc.) clinical trial that may confound study endpoints. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible
• Cerebral catheter angiographic evidence of pre-existing arterial disease, that potentially impacts treatment and/or outcome (for example, vasculitis)
• Any occlusion or stenosis that limits device access to the target area (for example, carotid dissection, tandem occlusions) or requiring acute stenting to achieve access
• Cerebral catheter angiographic evidence of multiple cerebrovascular occlusions, defined as occlusions in more than one vessel not downstream from each other (for example, bilateral anterior circulation, anterior/posterior circulation)
• Excessive vascular access tortuosity that will likely prevent endovascular access with the adaptive tip catheter (ATC)
• Baseline expanded thrombolysis in cerebral infarction (eTICI) > 1

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 · 5 центров

• CHU Bordeaux — Bordeaux
• CHU Nantes — Nantes
• CHU Pitie Salpetriere — Paris
• Centre Hospitalier Universitaire de Toulouse - Hopital Purpan — Toulouse
• CHRU de Tours — Tours

Германия · 4 центра

• Universitaetsklinikum Heidelberg — Heidelberg
• Universitatsklinikum Schleswig Holstein Kiel — Kiel
• Universitaetsmedizin Mainz — Mainz
• Stadtisches Klinikum Solingen gemeinnutzige GmbH — Solingen

Бельгия · 3 центра

• UZ Antwerpen — Edegem
• Ghent University Hospital — Ghent
• Universitair Ziekenhuis Leuven — Leuven

Нидерланды · 2 центра

• VUMC Amsterdam — Amsterdam
• Maastricht University Medical Centre — Maastricht

Ирландия · 1 центр

• Beaumont Hospital — Dublin

Идентификаторы

NCT: NCT07367100 · CNV202304

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗