Clinical trial NCT03290885: Combined Use of Contact Aspiration and the Stent Retriever Technique Versus Stent Retriever Alone for Recanalisation in Acute Cerebral Infarction
Official title: Combined Use of Contact Aspiration and the Stent Retriever Technique Versus Stent Retriever Alone for Recanalisation in Acute Cerebral Infarction: the Randomized ASTER2 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Ischemic Stroke
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2017-09-25
Enrollment: 408
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Mechanical thrombectomy (MT) with a stent retriever (SR) device is now the standard intervention in ischemic stroke with large vessel occlusion. Favorable outcome is strongly associated with the successful reperfusion status. New device of MT such as contact aspiration seems promising to increase reperfusion status and clinical outcome.

The main hypothesis is to show the superiority of combining the use of contact aspiration with a stent retriever compared to a stent retriever alone in treatment of acute stroke due to proximal arterial occlusion.

The primary endpoint is the rate of perfect reperfusion score at the end of the endovascular procedure.


Eligibility criteria: Inclusion Criteria:

* Age 18 and older (i.e., candidates must have had their 18th birthday)
* Groin puncture carried out within 8 hours of first symptoms
* Neuroimaging demonstrates large vessel proximal occlusion (distal ICA through MCA bifurcation, M1 or M2)
* Consenting requirements met according to French laws.
* With or without intravenous thrombolysis

Exclusion Criteria:

* Absence of large vessel occlusion on non-invasive imaging
* Known or suspected pre-existing (chronic) large vessel occlusion in the symptomatic territory
* Suspected pregnancy; if, a woman is of childbearing potential, a urine or serum beta human chorionic gonadotropin (betaHCG) test is positive.
* Severe contrast medium allergy or absolute contraindication to iodinated agents.
* Patient has severe or fatal comorbidities that will likely prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient.
* Acute ischemic stroke involving posterior circulation (vertebrobasilar occlusion)
* Angiographic evidence of carotid dissection or tandem cervical occlusion or stenosis requiring treatment.
* Patients benefiting from a legal protection
* Non-membership of a national insurance scheme
* Opposition of the patient or (in case of inclusion as a matter of urgency) of the trustworthy person

Primary outcomes:
measure: Perfect reperfusion rate
timeFrame: 24 hours
Secondary outcomes:
measure: Rate of successful reperfusion
timeFrame: 24 hours
measure: Rate of perfect (mTICI 2c/3), successful reperfusion (mTICI 2b/2c/3), and complete reperfusion (mTICI3) after the frontline strategy
timeFrame: 24 hours
measure: Time from groin puncture to achieve TICI 2c or better revascularization
timeFrame: 24 hours
measure: Time between groin puncture to clot contact and clot contact to maximum reperfusion
timeFrame: 24 hours
measure: Modified Rankin scale (mRs)
timeFrame: 90 days
measure: Rate of favorable functional independence
timeFrame: 90 days
measure: Rate of excellent functional outcome
timeFrame: 90 days
measure: NIHSS score
timeFrame: 24 hours
measure: Rate of symptomatic and asymptomatic intracerebral hemorrhage
timeFrame: 24 hours
measure: Rate of parenchymal hematoma
timeFrame: 90 days
measure: Rate of all-cause mortality
timeFrame: 90 days
measure: Rate of periprocedural complications
timeFrame: 90 days
measure: Average cost per patient
timeFrame: 90 days
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Limoges
country: France
facility: CHU Limoges
city: Montpellier
country: France
facility: CHU Montpellier
city: Nancy
country: France
facility: CHU Nancy
city: Nantes
country: France
facility: CHU Nantes
city: Paris
country: France
facility: Fondation Ophtalmologique Rotschild
city: Paris
country: France
facility: Kremlin-Bicêtre (APHP)
city: Paris
country: France
facility: La Pitié-Salpétrière (APHP)
city: Paris
country: France
facility: Lariboisière (APHP)
city: Rennes
country: France
facility: CHU Rennes
city: Suresnes
country: France
facility: Hôpital Foch
Study officials:
affiliation: Hôpital Foch
name: Bertrand Lapergue, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondation Ophtalmologique de Rothschild
name: Michel Piotin, MD
role: STUDY_CHAIR
References:
citation: Lapergue B, Blanc R, Costalat V, Desal H, Saleme S, Spelle L, Marnat G, Shotar E, Eugene F, Mazighi M, Houdart E, Consoli A, Rodesch G, Bourcier R, Bracard S, Duhamel A, Ben Maacha M, Lopez D, Renaud N, Labreuche J, Gory B, Piotin M; ASTER2 Trial Investigators. Effect of Thrombectomy With Combined Contact Aspiration and Stent Retriever vs Stent Retriever Alone on Revascularization in Patients With Acute Ischemic Stroke and Large Vessel Occlusion: The ASTER2 Randomized Clinical Trial. JAMA. 2021 Sep 28;326(12):1158-1169. doi: 10.1001/jama.2021.13827.