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

February 27, 2023 updated by: Hopital Foch

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

480

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: contact aspiration first line thrombectomy
Patient randomized in this arm will have the first arm thrombectomy by contact aspiration
Procedure: 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.
Sham Comparator: Stent retriever first line thrombectomy
Patient randomized in this arm will have the first arm thrombectomy by Stent retriever
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of first pass effect (FPE) defined by complete reperfusion after first device pass
Time Frame: 24 hours
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of complete reperfusion after first-line thrombectomy strategy and at the end of endovascular procedure
Time Frame: 24 hours

mTICI (modified Thrombolysis In Cerebral Infarction ) score equals to 3 after the first line thrombectomy and at the end of endovascular.

mTICI score is evaluated between 0-3 : 0 a complete obstruction of the artery and 3 indicates a complete reperfusion
24 hours
Rate of successful reperfusion (mTICI 2b/2c/3) after first-line thrombectomy strategy and at the end of endovascular procedure
Time Frame: 24 hours
mTICI score is evaluated between 0 to 3. Rate of patients with mTICI score equals to 2b/2c/3 after first-line thrombectomy strategy and at the end of endovascular procedure will be evaluated.
24 hours
Rate of near to complete reperfusion (mTICI 2c/3) after first-line thrombectomy strategy and at the end of endovascular procedure
Time Frame: 24 hours
24 hours
Rate of Arterial Occlusive Lesion (AOL) recanalization score III after first-line thrombectomy strategy and at the end of endovascular procedure
Time Frame: 24 hours

AOL recanalization score is evaluated between 0 to 3 :

  • 0 indicates no recanalization of the primary occlusive lesion
  • 3 indicates complete recanalization of the primary occlusive lesion with any distal flow
24 hours
Groin puncture time to successful reperfusion time (evaluated in minutes)
Time Frame: 360 minutes
360 minutes
Modified Rankin Score (mRS) at 3 and 12 months
Time Frame: 12 months
mRS is evaluated between 0 to 6. A score of 0 indicates that there is no disability and a score of 6 indicates death.
12 months
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)
Time Frame: 12 months
12 months
Quality of life at 90 days and 12 months assessed by EuroQol 5D-5L scale
Time Frame: 12 months
EuroQol 5D-5L comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
12 months
All cause of mortality at 90-day and 12 months
Time Frame: 12 months
12 months
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.
Time Frame: 24 hours
NIHSS (National Institutes of Health Stroke Scale) score is evaluated between 0-42 0 is normal and 42 maximal gravity
24 hours
Subgroups analysis : Age (≤70 vs. >70 years)
Time Frame: 24 hours
24 hours
Subgroups analysis :Baseline NIHSS≥10 vs NIHSS<10 (18)
Time Frame: 24 hours
24 hours
Subgroups analysis : Volume of infarct area assessed by pc-ASPECTS (≤7 vs. >7)
Time Frame: 24 hours
A pc-ASPECTS score of 10 indicates absence of visible ischemic changes in the posterior circulation, and pc-ASPECTS score of 0 indicates ischemic changes in the midbrain, pons, and bilateral thalami, posterior circulation territories, and cerebellar hemispheres
24 hours
Subgroups analysis : Time from admission of patient in hospital to randomization (≤ 300 vs. > 300 minutes)
Time Frame: 360 minutes
360 minutes
Subgroups analysis: Baseline site of thrombi on vascular imaging (Top of the basilar artery vs other adjudicated by the core lab)
Time Frame: 24 hours
24 hours
Subgroups analysis: Prior use of IV alteplase (yes vs. no)
Time Frame: 24 hours
24 hours
Subgroups analysis : Collateral status (good versus poor, as adjudicated by the core lab on initial angiogram) with a 0-3 scale
Time Frame: 24 hours
Collateral circulation is estimated by angiography with a 0-3 scale. The collateral status will be categorized as poor collaterals (scores 0-1) and good collaterals (scores 2-3)
24 hours
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)
Time Frame: 24 hours

ECASS III (European Cooperative Acute Stroke Study) classification :

  • Hemorrhage infarction type 1 (HI1)
  • Hemorrhage infarction type 2 (HI2)
  • Parenchymal hematoma type 1 (PH1)
  • Parenchymal hematoma type 2 (PH2)
24 hours
Incidence of procedure-related complications defined as arterial perforation, arterial dissection, embolization in a new territory (ENT) and subarachnoid haemorrhage
Time Frame: hours
hours
Cost-effectiveness analysis at 12 months
Time Frame: 12 months
Incremental cost-effectiveness ratio (ICER, cost per quality-adjusted life year [QALY]), of Contact Aspiration (CA) first-line thrombectomy compared to standard first-line SR thrombectomy in treatment of AIS due to BAO, from a collective perspective and with a 12-months' time horizon.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Foch

Investigators

  • Principal Investigator: Arturo CONSOLI, Study Principal Investigator
  • Study Chair: Benjamin GORY, Scientific Director

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2022

Primary Completion (Anticipated)

July 1, 2026

Study Completion (Anticipated)

July 1, 2027

Study Registration Dates

First Submitted

February 14, 2022

First Submitted That Met QC Criteria

April 1, 2022

First Posted (Actual)

April 11, 2022

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 27, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018_0105

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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