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Contact Aspiration Versus Stent Retriever for Recanalisation of Acute Stroke Patients With Basilar Artery Occlusion: The Posterior Circulation ASTER Randomized Trial Protocol
Sponsor: Hopital Foch
Summary
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.
Official title: Contact Aspiration Versus Stent Retriever for Recanalisation of Acute Stroke Patients With Basilar Artery Occlusion: The Posterior Circulation ASTER Randomized Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
480
Start Date
2022-11-19
Completion Date
2027-07
Last Updated
2023-03-01
Healthy Volunteers
No
Conditions
Interventions
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 thrombus. After a 3 min waiting period, the large-bore aspiration catheter is connected to a continuous aspiration from the dedicated aspiration pump while simultaneously advancing the aspiration catheter up to the face of the thrombus. through the long sheath positioned in the cervical vasculature.
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 minimum of 3 attempts with SR should be performed. A revascularization score will be recorded after each device attempt.
Locations (12)
Chu Bordeaux
Bordeaux, France
CHU Caen
Caen, France
CHU Limoges
Limoges, France
CHU Montpellier
Montpellier, France
Chru Nancy
Nancy, France
Chu Nantes
Nantes, France
APHP - Pitié Salpêtrière
Paris, France
Fondation Adolphe de Rothschild
Paris, France
CHU de Reims
Reims, France
CHU Rennes
Rennes, France
Hôpital FOCH
Suresnes, France
CHU de Tours
Tours, France