The Use of p48/64 MW HPC Flow Modulation Device in the Treatment of Wide-necked Intracranial Aneurysms

Официальное название

p48/64 MW HPC in Aneurysm Occlusion (PIANO): Prospective, Multicenter, Single-arm Clinical Trial to Determine Safety and Effectiveness of the Flow Modulation Device in the Treatment of Wide-necked Intracranial Aneurysms.

Обзор

To determine safety and effectiveness of the p48 MW HPC and p64 MW HPC Flow Modulation Device in the treatment of wide-necked intracranial aneurysms.

Подробное описание

To assess safety, effectiveness, and performance of the p48/p64 MW HPC Flow Modulation Device in the endovascular treatment of wide-necked intracranial aneurysms (IA) at 12 months post-procedure.

Вмешательства

• Устройство Flow diversion
  The p48 MW HPC and p64 MW HPC Flow Modulation Device is indicated for use in the treatment of intracranial aneurysms (IAs) arising from a parent vessel with a diameter of ≥2.0mm and ≤5.0 mm.

Первичные конечные точки

• Primary Efficacy and Performance Endpoint: Number of subjects with 100% occlusion of the target aneurysm without significant parent artery stenosis and no retreatment of the target aneurysm from the index procedure to the 12-month follow-up visit. [Срок оценки: 12 months]
• The Primary Safety Endpoint: Number of subjects with ischemic or hemorrhagic stroke or neurologic death from treatment to 12-months, as adjudicated by a Clinical Events Committee. [Срок оценки: From treatment - 12 months]

Вторичные конечные точки (3)

• Secondary Safety Endpoint #1: Number of subjects with a modified Rankin Scale (mRS) score > 2 [Срок оценки: 30 days post procedure and at the following timepoints: 6-month, 1 year, 3 years, and 5 years]
• Secondary Safety Endpoint #2: Number of subjects with procedural and/or device-related serious adverse events (SAE) [Срок оценки: 30 days post procedure and at the following timepoints: 6-months, 1 year, 3 years, and 5 years]
• Secondary Safety Endpoint #3: Number of subjects with a neurologic event of interest defined as any death, neurological death, target aneurysm rupture or re-rupture, target aneurysm retreatment, or intracranial hemorrhage [Срок оценки: 30 days post procedure and at the following timepoints: 6-months and 12-months post procedure]

Критерии участия

Критерии включения

• Subject is ≥ 18 years
• Subject has a mRS ≤2 before the index procedure
• Subject has an unruptured or recanalized intracranial aneurysm (IA). The subject may also have a previous ruptured aneurysm, provided rupture of this aneurysm has occurred more than 30 days from the index procedure. The IA must have the following characteristics below:

• Saccular or fusiform morphology
• Located in the internal carotid artery and its branches
• Aneurysm neck ≥4 mm or dome-to-neck ratio <2
• Parent vessel diameter ≥2.0mm and ≤5.0mm both distal and proximal to the target IA
• Subject or subject's legally authorized representative (LAR) has provided written informed consent and has agreed to comply with study procedures.

Критерии исключения

• Previous flow diverter or stent within the parent vessel of the target aneurysm to be treated
• Any other known IA requiring treatment within 3 months post-procedure
• Subarachnoid hemorrhage in the past 30 days prior to the index procedure
• Has a true bifurcation aneurysm, defined as an aneurysm (saccular or non-saccular) located at the point of vessel bifurcation
• Anatomy unsuitable for endovascular procedure due to severe vessel tortuosity or stenosis, or stented ipsilateral carotid artery within 3 months prior to the index procedure
• Subject with a brain arteriovenous malformation (AVM) or other vascular malformation in the area of the target aneurysm
• Major surgery in the last 30 days, including endovascular procedures, or is planned in the next 90 days after enrollment date
• Unstable neurologic deficit (i.e., any worsening of clinical condition in the last 30 days)
• Known serious sensitivity to radiographic contrast agents that cannot be managed medically
• Known sensitivity to nickel, titanium metals or their alloys or any other investigational device components
• Irreversible bleeding disorder and/or signs of active bleeding at subject presentation
• Known renal failure with a serum creatinine >2.5 mg/dl (or 220 μmol/l) not on dialysis
• Contraindication to CT scan, MRI, or angiography
• Contraindication or known allergies to anticoagulants or antiplatelets (e.g. aspirin, heparin, clopidogrel, prasugrel, or ticagrelor)
• Known coagulopathy, or an admission International Normalized Ratio >3.0 without oral anticoagulation therapy, or an admission platelet count of <100000
• Has acute life-threatening illness other than the neurological disease (i.e., acute kidney or heart failure) to be treated in this trial
• Unable to complete the required study follow-ups
• Evidence of active infection at the time of treatment (e.g., fever, elevated white blood cell count)
• Participating in another clinical trial that could affect participation or primary outcomes of this study
• Women currently pregnant or wish to become pregnant during the study or breast feeding.

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

США · 21 центр

• Barrow Neurological Institute — Phoenix
• UCSF Medical Center — San Francisco
• University of Colorado Anschutz — Aurora
• Swedish Medical Research Center — Englewood
• Baptist Health Research Institute — Jacksonville
• Piedmont Atlanta Hospital — Atlanta
• Advocate Lutheran General Hospital — Park Ridge
• University of Iowa — Iowa City
• … и ещё 13 центров

Идентификаторы

NCT: NCT07143019 · pCT-002-23

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗