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

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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

Locations
Other Locations
France
Chu Bordeaux
RECRUITING
Bordeaux
CHU Caen
NOT_YET_RECRUITING
Caen
CHU Limoges
NOT_YET_RECRUITING
Limoges
CHU Montpellier
NOT_YET_RECRUITING
Montpellier
Chru Nancy
RECRUITING
Nancy
Chu Nantes
NOT_YET_RECRUITING
Nantes
APHP - Pitié Salpêtrière
NOT_YET_RECRUITING
Paris
Fondation Adolphe de Rothschild
RECRUITING
Paris
CHU de Reims
NOT_YET_RECRUITING
Reims
CHU Rennes
NOT_YET_RECRUITING
Rennes
Hôpital FOCH
RECRUITING
Suresnes
CHU de Tours
NOT_YET_RECRUITING
Tours
Contact Information
Primary
Arturo CONSOLI
a.consoli@hopital-foch.com
0033146251955
Backup
Bertrand LAPERGUE
b.lapergue@hopital-foch.com
0033146255973
Time Frame
Start Date: 2022-11-19
Estimated Completion Date: 2027-07
Participants
Target number of participants: 480
Treatments
Experimental: contact aspiration first line thrombectomy
Patient randomized in this arm will have the first arm thrombectomy by contact aspiration
Sham_comparator: Stent retriever first line thrombectomy
Patient randomized in this arm will have the first arm thrombectomy by Stent retriever
Related Therapeutic Areas
Sponsors
Leads: Hopital Foch

This content was sourced from clinicaltrials.gov