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

Hopital Foch408 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

408

Conditions

Acute Ischemic Stroke

Interventions

Combined contact aspiration/SR is performed using a balloon-guide catheter (BGC). A 0.021 to 0.027 inch inner lumen microcatheter with a 0.014 to 0.016 inch micro-wire inside is introduced into a large-bore aspiration catheter and this construct is introduced into BGC. The BGC is placed into the origin of the cervical internal carotid artery (ICA). The catheter is advanced past the thrombus over the micro-wire to allow the SR deployment. The SR is deployed across the occlusion. Then the large bore distal access catheter is advanced to contact the proximal edge of the SR. The aspiration pump is connected to the large bore distal access catheter. After at least 90 sec, the SR and the large bore distal access catheter are pulled out as an unit from the BGC and the patient. Manual aspiration is also be applied to the BGC during the pull-out manoeuver which is performed after the temporary inflation of the balloon at the tip of the BGC to ensure flow arrest into the carotid

Stent retriever techniqueDEVICE

The technique used should be in accordance with the device instruction for use. A large bore balloon guide catheter has to be placed into the cervical ICA. A suitable delivery microcatheter is navigated over a micro-wire into the occluded major coronary artery MCA and across the occlusion. A control superselective angiogram may be used to document the extent of occlusion and thrombus. The stent retriever device is then deployed across the occlusion. After at least 90 seconds, removal should occur with proximal occlusion by inflation of the balloon guide catheter.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (11)

CHU Bordeaux

Bordeaux, France

CHU Limoges

Limoges, France

CHU Montpellier

Montpellier, France

CHU Nancy

Nancy, France

CHU Nantes

Nantes, France

Fondation Ophtalmologique Rotschild

Paris, France

Kremlin-Bicêtre (APHP)

Paris, France

La Pitié-Salpétrière (APHP)

Paris, France

Lariboisière (APHP)

Paris, France

CHU Rennes

Rennes, France

...and 1 more locations

Outcomes

Primary Outcomes

Perfect reperfusion rate

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)

Time frame: 24 hours

Secondary Outcomes

Rate of successful reperfusion

Rate of successful reperfusion (mTICI 2b/2c/3), and complete reperfusion (mTICI3) at end of endovascular procedure

Time frame: 24 hours

Rate of perfect (mTICI 2c/3), successful reperfusion (mTICI 2b/2c/3), and complete reperfusion (mTICI3) after the frontline strategy

Time frame: 24 hours

Time from groin puncture to achieve TICI 2c or better revascularization

Time frame: 24 hours

Time between groin puncture to clot contact and clot contact to maximum reperfusion

Time frame: 24 hours

Modified Rankin scale (mRs)

Global disability assessed by overall distribution of mRs at 90-days

Time frame: 90 days

Rate of favorable functional independence

Rate of favorable functional independence defined as a mRS 0-2 at 90 days

Time frame: 90 days

Rate of excellent functional outcome

Rate of excellent functional outcome defined as a Modified Rankin scale (mRS) 0-1 at 90 days

Time frame: 90 days

NIHSS score

Change in NIHSS from baseline to 24 hours (delta NIHSS)

Time frame: 24 hours

Rate of symptomatic and asymptomatic intracerebral hemorrhage

Rate of symptomatic and asymptomatic intracerebral hemorrhage at MRI 24h after thrombectomy (according the third European Cooperative Acute Stroke Study (ECASS3) classification) (independent core lab adjudication).

Time frame: 24 hours

Rate of parenchymal hematoma

Time frame: 90 days

Rate of all-cause mortality

Time frame: 90 days

Rate of periprocedural complications

\- Rate of periprocedural complications: Occurrence of emboli to new territory (ENT), vasospasm, dissection, or perforation.

Time frame: 90 days

Average cost per patient

Average cost per patient with complete recanalization

Time frame: 90 days