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

NCT05320263 | Recruiting DMC

• 1 other identifier: 2018_0105
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

Basilar Artery Occlusion

Keywords

Stroke; Basilar artery occlusion

Outcome Measures

Primary Outcomes (1)

• Rate of first pass effect (FPE) defined by complete reperfusion after first device pass

  The definition of FPE: single pass/use of the device, (2) complete revascularization of the large vessel occlusion and its downstream territory (mTICI 3), and (3) no use of rescue therapy

  24 hours

Secondary Outcomes (20)

• Rate of complete reperfusion after first-line thrombectomy strategy and at the end of endovascular procedure

  24 hours

• Rate of successful reperfusion (mTICI 2b/2c/3) after first-line thrombectomy strategy and at the end of endovascular procedure

  24 hours

• Rate of near to complete reperfusion (mTICI 2c/3) after first-line thrombectomy strategy and at the end of endovascular procedure

  24 hours

• Rate of Arterial Occlusive Lesion (AOL) recanalization score III after first-line thrombectomy strategy and at the end of endovascular procedure

  24 hours

• Groin puncture time to successful reperfusion time (evaluated in minutes)

  360 minutes

Study Arms (2)

contact aspiration first line thrombectomy

EXPERIMENTAL

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

Procedure: Contact aspiration Thrombectomy

Stent retriever first line thrombectomy

SHAM COMPARATOR

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

Procedure: Stent retriever thrombectomy

Interventions

Contact aspiration Thrombectomy 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.

contact aspiration first line thrombectomy

Stent retriever thrombectomy 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.

Stent retriever first line thrombectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (12)

Chu Bordeaux

Bordeaux, France

RECRUITING

CHU Caen

Caen, France

NOT YET RECRUITING

CHU Limoges

Limoges, France

NOT YET RECRUITING

CHU Montpellier

Montpellier, France

NOT YET RECRUITING

Chru Nancy

Nancy, France

RECRUITING

Chu Nantes

Nantes, France

NOT YET RECRUITING

APHP - Pitié Salpêtrière

Paris, France

NOT YET RECRUITING

Fondation Adolphe de Rothschild

Paris, France

RECRUITING

CHU de Reims

Reims, France

NOT YET RECRUITING

CHU Rennes

Rennes, France

NOT YET RECRUITING

Hôpital FOCH

Suresnes, France

RECRUITING

CHU de Tours

Tours, France

NOT YET RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Arturo CONSOLI

  Study principal investigator

  PRINCIPAL INVESTIGATOR

• Benjamin GORY

  Scientific director

  STUDY CHAIR

Central Study Contacts

Arturo CONSOLI

CONTACT

0033146251955; a.consoli@hopital-foch.com

Bertrand LAPERGUE

CONTACT

0033146255973; b.lapergue@hopital-foch.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: April 11, 2022
• Study Start: November 19, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 1, 2023

Record last verified: 2023-02

Locations

FR (12)