Clinical trial NCT05320263: Contact Aspiration Versus Stent Retriever for Recanalisation of Acute Stroke Patients With Basilar Artery Occlusion: The Posterior Circulation ASTER Randomized Trial Protocol
Official title: Contact Aspiration Versus Stent Retriever for Recanalisation of Acute Stroke Patients With Basilar Artery Occlusion: The Posterior Circulation ASTER Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Basilar Artery Occlusion
Keywords: Stroke
Basilar artery occlusion
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2022-04-11
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Rate of first pass effect (FPE) defined by complete reperfusion after first device pass
timeFrame: 24 hours
Secondary outcomes:
measure: Rate of complete reperfusion after first-line thrombectomy strategy and at the end of endovascular procedure
timeFrame: 24 hours
measure: Rate of successful reperfusion (mTICI 2b/2c/3) after first-line thrombectomy strategy and at the end of endovascular procedure
timeFrame: 24 hours
measure: Rate of near to complete reperfusion (mTICI 2c/3) after first-line thrombectomy strategy and at the end of endovascular procedure
timeFrame: 24 hours
measure: Rate of Arterial Occlusive Lesion (AOL) recanalization score III after first-line thrombectomy strategy and at the end of endovascular procedure
timeFrame: 24 hours
measure: Groin puncture time to successful reperfusion time (evaluated in minutes)
timeFrame: 360 minutes
measure: Modified Rankin Score (mRS) at 3 and 12 months
timeFrame: 12 months
measure: Rate of good functional outcome at 90-day and at one year defined by a mRS 0-3 or equal to pre-stroke mRS (Modified Rankin Score)
timeFrame: 12 months
measure: Quality of life at 90 days and 12 months assessed by EuroQol 5D-5L scale
timeFrame: 12 months
measure: All cause of mortality at 90-day and 12 months
timeFrame: 12 months
measure: 24-hours change in NIHSS (National Institutes of Health Stroke Scale) from baseline defined as the difference between NIHSS score at 24 hours and NIHSS score at admission.
timeFrame: 24 hours
measure: Subgroups analysis : Age (≤70 vs. >70 years)
timeFrame: 24 hours
measure: Subgroups analysis :Baseline NIHSS≥10 vs NIHSS<10 (18)
timeFrame: 24 hours
measure: Subgroups analysis : Volume of infarct area assessed by pc-ASPECTS (≤7 vs. >7)
timeFrame: 24 hours
measure: Subgroups analysis : Time from admission of patient in hospital to randomization (≤ 300 vs. > 300 minutes)
timeFrame: 360 minutes
measure: Subgroups analysis: Baseline site of thrombi on vascular imaging (Top of the basilar artery vs other adjudicated by the core lab)
timeFrame: 24 hours
measure: Subgroups analysis: Prior use of IV alteplase (yes vs. no)
timeFrame: 24 hours
measure: Subgroups analysis : Collateral status (good versus poor, as adjudicated by the core lab on initial angiogram) with a 0-3 scale
timeFrame: 24 hours
measure: Incidence of any intracerebral hemorrhage (ICH), parenchymal hematoma (PH), symptomatic ICH on brain imaging (Magnetic resonance imaging MRI or CT (computed tomography) scan) at 24±12h after thrombectomy (according to ECASS3 classification)
timeFrame: 24 hours
measure: Incidence of procedure-related complications defined as arterial perforation, arterial dissection, embolization in a new territory (ENT) and subarachnoid haemorrhage
timeFrame: hours
measure: Cost-effectiveness analysis at 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Chu Bordeaux
city: Caen
country: France
facility: CHU Caen
city: Limoges
country: France
facility: CHU Limoges
city: Montpellier
country: France
facility: CHU Montpellier
city: Nancy
country: France
facility: Chru Nancy
city: Nantes
country: France
facility: Chu Nantes
city: Paris
country: France
facility: APHP - Pitié Salpêtrière
city: Paris
country: France
facility: Fondation Adolphe de Rothschild
city: Reims
country: France
facility: CHU de Reims
city: Rennes
country: France
facility: CHU Rennes
city: Suresnes
country: France
facility: Hôpital FOCH
city: Tours
country: France
facility: CHU de Tours
Study officials:
affiliation: Study principal investigator
name: Arturo CONSOLI
role: PRINCIPAL_INVESTIGATOR
affiliation: Scientific director
name: Benjamin GORY
role: STUDY_CHAIR
References: