Combined Use of Contact Aspiration and the Stent Retriever Technique Versus Stent Retriever Alone for Recanalisation in Acute Cerebral Infarction: the Randomized ASTER2 Study

Hopital Foch11 sites in 1 country408 target enrollmentOctober 16, 2017

ConditionsAcute Ischemic Stroke

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Acute Ischemic Stroke
Sponsor: Hopital Foch
Enrollment: 408
Locations: 11
Primary Endpoint: Perfect reperfusion rate
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 16, 2017

End Date

February 28, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hopital Foch

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Perfect reperfusion rate

Time Frame: 24 hours

Perfect reperfusion rate at the end of angiography defined as a Thrombolysis In Cerebral Infarction (TICI) 2c/3 score (TICI score = Thrombolysis In Cerebral Infarction)

Secondary Outcomes

Rate of periprocedural complications(90 days)
Average cost per patient(90 days)
Modified Rankin scale (mRs)(90 days)
Rate of symptomatic and asymptomatic intracerebral hemorrhage(24 hours)
Rate of all-cause mortality(90 days)
Rate of favorable functional independence(90 days)
Rate of excellent functional outcome(90 days)
NIHSS score(24 hours)
Rate of successful reperfusion(24 hours)
Rate of perfect (mTICI 2c/3), successful reperfusion (mTICI 2b/2c/3), and complete reperfusion (mTICI3) after the frontline strategy(24 hours)
Rate of parenchymal hematoma(90 days)
Time from groin puncture to achieve TICI 2c or better revascularization(24 hours)
Time between groin puncture to clot contact and clot contact to maximum reperfusion(24 hours)