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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-19

Study Completion Date

2027-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Basilar Artery Occlusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

It is planned to include a total of 480 patients (240 per am) to show with a 80% power an 12% increase in FPE rate at end of MT with contact aspiration technique, assuming 23 % of FPE in control arm, 5% of spontaneous recanalization and considering one interim futility analysis

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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contact aspiration first line thrombectomy

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

Group Type EXPERIMENTAL

Contact aspiration Thrombectomy

Intervention Type PROCEDURE

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 first line thrombectomy

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

Group Type SHAM_COMPARATOR

Stent retriever thrombectomy

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arturo CONSOLI

Role: PRINCIPAL_INVESTIGATOR

Study principal investigator

Benjamin GORY

Role: STUDY_CHAIR

Scientific director

Locations

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Chu Bordeaux

Bordeaux, , France

Site Status RECRUITING