Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05320263

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

Led by Hopital Foch · Updated on 2023-03-01

480

Participants Needed

12

Research Sites

240 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Acute ischemic stroke with basilar artery occlusion confirmed by CT or MRI
  • Eligible for thrombectomy with groin puncture within 24 hours of symptom onset or last known normal time
  • Covered by a national health insurance
  • Informed consent obtained from patient or proxy, or following emergency procedures
Not Eligible

You will not qualify if you...

  • Known or suspected chronic large vessel stenosis or occlusion in the basilar artery
  • Severe allergy or absolute contraindication to iodinated contrast media
  • Clinical history or imaging suggesting intracranial basilar artery stenosis
  • Pregnancy (confirmed by urine or serum beta HCG test in women of childbearing potential)
  • Person deprived of liberty
  • Patient under legal protection such as guardianship or curatorship

AI-Screening

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Trial Site Locations

Total: 12 locations

1

Chu Bordeaux

Bordeaux, France

Actively Recruiting

2

CHU Caen

Caen, France

Not Yet Recruiting

3

CHU Limoges

Limoges, France

Not Yet Recruiting

4

CHU Montpellier

Montpellier, France

Not Yet Recruiting

5

Chru Nancy

Nancy, France

Actively Recruiting

6

Chu Nantes

Nantes, France

Not Yet Recruiting

7

APHP - Pitié Salpêtrière

Paris, France

Not Yet Recruiting

8

Fondation Adolphe de Rothschild

Paris, France

Actively Recruiting

9

CHU de Reims

Reims, France

Not Yet Recruiting

10

CHU Rennes

Rennes, France

Not Yet Recruiting

11

Hôpital FOCH

Suresnes, France

Actively Recruiting

12

CHU de Tours

Tours, France

Not Yet Recruiting

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Research Team

A

Arturo CONSOLI

CONTACT

B

Bertrand LAPERGUE

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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