The Pivotal Study of RapidPulseTM Aspiration System

Официальное название

The Pivotal Study of RapidPulseTM Aspiration System as Frontline Approach for Patient With Acute Ischemic Stroke Due to Large Vessel Occlusions

Обзор

The goal of this clinical trials is to demonstrate the safety and effectiveness for the RapidPulseTM Aspiration System in patients experiencing acute ischemic stroke within 8 hours of symptom onset or last seen normal. Subjects will undergo mechanical thrombectomy (a procedure to remove a clot in the brain which is preventing blood flow), with the RapidPulseTM Aspiration System. Participation in the trial is for 90 days.

Подробное описание

The purpose of this prospective, open label clinical trials is to demonstrate the safety and effectiveness for the RapidPulseTM Aspiration System as frontline approach in the treatment of large vessel occlusions in patients experiencing Acute Ischemic Stroke within 8 hours of symptom onset or last seen normal. The target sample size for this clinical trial is 170 subjects enrolled in up to 30 sites globally. The maximum number of subjects that may be enrolled is 340. Subjects will undergo mechanical thrombectomy procedure and will have postoperative assessments completed at 24 hours and on day 5-7 or hospital discharge (whichever comes first). The final study visit will occur approximately 90 days after the index event. The primary effectiveness endpoint is the proportion of patients who achieve First Pass Reperfusion Effect (FPE) as defined by modified treatment in cerebral infarction score (mTICI) ≥ 2c after the first pass as assessed by an independent Imaging Core Lab. The primary safety endpoint is the proportion of patients with symptomatic ICH (sICH) at 24 hours post-thrombectomy as assessed by a central events committee (CEC).

Вмешательства

• Устройство RapidPulseTM Aspiration System
  The RapidPulseTM Aspiration System is designed to remove occlusive thrombus from the occluded cerebral vasculature using precisely pulsed aspiration. The system is comprised of the multi-use, non-sterile RapidPulseTM Aspiration Pump, the single use, sterile RapidPulseTM Tube set, the single use, non-sterile RapidPulseTM Collection Canister and the single use, sterile RapidPulseTM 071 Catheter.

Первичные конечные точки

• Rate of First Pass Reperfusion Effect (FPE) [Срок оценки: Intra-procedural]
• Rate of symptomatic intracranial hemorrhage (sICH) [Срок оценки: Post-procedural (24 hours post-thrombectomy)]

Вторичные конечные точки (2)

• Rate of reperfusion after all study device passes [Срок оценки: Intra-procedural]
• Modified Rankin Scale (mRS) at 90 days post treatment [Срок оценки: Post-procedure (90 days post-thrombectomy)]

Критерии участия

Критерии включения

• Age 18 to 80 years
• Clinical diagnosis of acute ischemic stroke with NIH Stroke Scale (NIHSS) score ≥ 6
• Able to be treated within 8 hours of symptom onset or last known normal (LKN)
• Able to be treated within 120 minutes from the time of the qualifying baseline CT/MR image
• Pre-morbid Modified Rankin Scale (mRS) score 0-1
• Angiographic confirmation of large vessel occlusion (LVO) in the anterior (intracranial ICA or MCA M1 or M2 segments) or posterior circulation (vertebral or basilar arteries) as confirmed by digital subtraction angiography (DSA) irrespective of IV thrombolysis administration
• Candidate to receive treatment with ADAPT technique (Direct Aspiration First-Pass Technique)

Критерии исключения

• Intracranial Hemorrhage (ICH)
• Alberta Stroke Program Early CT Score (ASPECTS) <6
• Intracranial Atherosclerotic Disease (ICAD)
• Multiple or tandem occlusions
• Life expectancy less than 6 months

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 · 18 центров

• Providence Saint John's Medical Foundation — Torrance
• Yale University — New Haven
• Baptist Health Research Institute — Jacksonville
• University of South Florida — Tampa
• Emory University at Grady — Atlanta
• Rush University Medical Center — Chicago
• Advocate Aurora Research Institute — Park Ridge
• Indiana University Health — Indianapolis
• … и ещё 10 центров

Испания · 8 центров

• Hospital General Universitario Dr. Balmis — Alicante
• Hospital Universitari Germans Trias i Pujol — Badalona
• Hospital Universitari Vall d' Hebron — Barcelona
• Hospital Universitari de Bellvitge — Barcelona
• Hospital Universitari de Girona Dr. Josep Trueta — Girona
• Hospital Universitario de la Princesa — Madrid
• Hospital Universitario 12 de Octubre — Madrid
• Hospital Universitario La Paz — Madrid

Франция · 3 центра

• Centre Hospitalier Universitaire de Bordeaux — Bordeaux
• Centre Hospitalier Universitaire de Montpellier — Montpellier
• Centre Hospitalier Universitaire de Toulouse — Toulouse

Turkey (Türkiye) · 1 центр

• Istanbul Aydan Universitesi VM Medical Park Florya Hastanesi — Istanbul

Идентификаторы

NCT: NCT06029491 · CIP-0002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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