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

Hopital Foch

Status: Completed

Conditions: Acute Ischemic Stroke

Treatments: Combination Product: Combined contact aspiration/Stent Retriever Technique; Device: Stent retriever technique

Study type: Interventional

Funder types: Other

Identifiers

NCT03290885

2016-A01735-46 (Other Identifier)

2017014F

Details and patient eligibility

About

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.

Enrollment: 408 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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408 participants in 2 patient groups

Combined use of contact aspiration and stent retriever

Experimental group

Description:

Combined use of contact aspiration and stent retriever mechanical thrombectomy for recanalization

Treatment:

Combination Product: Combined contact aspiration/Stent Retriever Technique

Stent retriever mechanical thrombectomy alone

Active Comparator group

Description:

Stent retriever mechanical thrombectomy alone for recanalisation

Treatment:

Device: Stent retriever technique