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

Hopital Foch

Status: Enrolling

Conditions: Basilar Artery Occlusion

Treatments: Procedure: Contact aspiration Thrombectomy; Procedure: Stent retriever thrombectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05320263

2018_0105

Details and patient eligibility

About

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.

Enrollment: 480 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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480 participants in 2 patient groups

contact aspiration first line thrombectomy

Experimental group

Description:

Patient randomized in this arm will have the first arm thrombectomy by contact aspiration

Treatment:

Procedure: Contact aspiration Thrombectomy

Stent retriever first line thrombectomy

Sham Comparator group

Description:

Patient randomized in this arm will have the first arm thrombectomy by Stent retriever

Treatment:

Procedure: Stent retriever thrombectomy