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

Not yet recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Combined contact aspiration/Stent Retriever Technique Combination Product
    Intervention Desc: 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
    ARM 1: Kind: Experimental
    Label: Combined use of contact aspiration and stent retriever
    Description: Combined use of contact aspiration and stent retriever mechanical thrombectomy for recanalization
  • Stent retriever technique Device
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Stent retriever mechanical thrombectomy alone
    Description: Stent retriever mechanical thrombectomy alone for recanalisation

Outcomes

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

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