Contact Aspiration Versus Stent Retriever for Recanalisation of Acute Stroke Patients With Basilar Artery Occlusion: The Posterior Circulation ASTER Randomized Trial Protocol

Официальное название

Contact Aspiration Versus Stent Retriever for Recanalisation of Acute Stroke Patients With Basilar Artery Occlusion: The Posterior Circulation ASTER Randomized Trial

Обзор

Acute ischemic stroke (AIS) patients with basilar artery occlusion (BAO) present a devastating, life-threatening prognosis. Urgent recanalization with endovascular mechanical thrombectomy is routinely performed in patients with BAO although the level of evidence is lower than that in anterior circulation occlusions (randomization in this population versus medical treatment alone having been impossible in recent studies). Recently, a large retrospective study supports the interest of thrombectomy in this population . Speed and grade of the recanalisation have a major impact on clinical outcome. Favorable outcome at 90 days is strongly associated with the successful recanalization status at the end of the endovascular procedure (OR=4.57, 95%CI=1.24-16.87, P=0.023). First pass effect has been shown to be a strong marker of efficacy of endovascular procedure with significant correlation with clinical outcome. Thrombectomy with Stent retrievers dramatically changed the prognosis of anterior circulation large vessel occlusion strokes and currently used in BAO patients (posterior circulation). Contact aspiration (CA) is currently used in anterior large vessel occlusions (COMPASS trial, Lancet 2019), with similar rates of recanalization and favorable outcomes (Boulanger M, 2019), as well as in BAO patients . However, the benefit of CA compared to SR for the treatment of BAO remains under debate with the superiority of first line CA compared to SR or no difference. Available data are based on retrospective studies with no data from RCT. In this context, a randomized controlled trial is needed to assess the benefit of CA versus SR.

Вмешательства

• Процедура Contact aspiration Thrombectomy
  The contact aspiration approach is performed, as in standard care, using a long sheath positioned in the distal cervical vasculature using an exchange technique. A large bore balloon guide catheter as to be placed into the cervical ICA. The microcatheter is then advanced close to the thrombus and the large-bore aspiration catheter is advanced as close to the proximal aspect of the thrombus as possible. A control superselective angiogram may be used to document the extent of occlusion and thromb
• Процедура Stent retriever thrombectomy
  The technique used should be in accordance with the device IFU. A large bore access guide catheter possible is recommended. A suitable delivery microcatheter is navigated over a microwire across the occlusion. A control superselective angiogram may be used to document the extent of occlusion and thrombus. The stent is left in place according to the internal practice of each participating center before the withdrawal. Any CE-marked stent retriever device is then deployed across the occlusion. A m

Первичные конечные точки

• Rate of first pass effect (FPE) defined by complete reperfusion after first device pass [Срок оценки: 24 hours]

Вторичные конечные точки (12)

• Rate of complete reperfusion after first-line thrombectomy strategy and at the end of endovascular procedure [Срок оценки: 24 hours]
• Rate of successful reperfusion (mTICI 2b/2c/3) after first-line thrombectomy strategy and at the end of endovascular procedure [Срок оценки: 24 hours]
• Rate of near to complete reperfusion (mTICI 2c/3) after first-line thrombectomy strategy and at the end of endovascular procedure [Срок оценки: 24 hours]
• Rate of Arterial Occlusive Lesion (AOL) recanalization score III after first-line thrombectomy strategy and at the end of endovascular procedure [Срок оценки: 24 hours]
• Groin puncture time to successful reperfusion time (evaluated in minutes) [Срок оценки: 360 minutes]
• Modified Rankin Score (mRS) at 3 and 12 months [Срок оценки: 12 months]
• Rate of good functional outcome at 90-day and at one year defined by a mRS 0-3 or equal to pre-stroke mRS (Modified Rankin Score) [Срок оценки: 12 months]
• Quality of life at 90 days and 12 months assessed by EuroQol 5D-5L scale [Срок оценки: 12 months]
• All cause of mortality at 90-day and 12 months [Срок оценки: 12 months]
• 24-hours change in NIHSS (National Institutes of Health Stroke Scale) from baseline defined as the difference between NIHSS score at 24 hours and NIHSS score at admission. [Срок оценки: 24 hours]
• Subgroups analysis : Age (≤70 vs. >70 years) [Срок оценки: 24 hours]
• Subgroups analysis :Baseline NIHSS≥10 vs NIHSS<10 (18) [Срок оценки: 24 hours]

Критерии участия

Критерии включения

Age ≥ 18 years

• AIS with BAO on non-invasive imaging (CT or MRI)
• Eligible for thrombectomy : groin puncture undergone within 24 hours of first symptoms or of last time the patient was seen normal
• Being covered by a national health insurance
• Informed consent obtained from the patients/his proxy or following an emergency procedure

Критерии исключения

• Known or suspected pre-existing (chronic) large vessel stenosis / occlusion in the symptomatic territory (basilar artery)
• Severe contrast medium allergy or absolute contraindication to use of iodinated products
• Clinical history, past imaging or clinical judgment suggesting intracranial stenosis of the basilar artery
• Pregnancy (urine or serum beta HCG test for women of child-bearing potential)
• Person deprived of liberty
• Patient benefiting from a legal protection (guardianship or curatorship)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 12 центров

• Chu Bordeaux — Bordeaux
• CHU Caen — Caen
• CHU Limoges — Limoges
• CHU Montpellier — Montpellier
• Chru Nancy — Nancy
• Chu Nantes — Nantes
• APHP - Pitié Salpêtrière — Paris
• Fondation Adolphe de Rothschild — Paris
• … и ещё 4 центра

Идентификаторы

NCT: NCT05320263 · 2018_0105

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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