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

NCT ID: NCT03290885

Last Updated: 2020-05-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 408 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-16
• Study Completion Date: 2020-02-28

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.

Conditions

Acute Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Combined use of contact aspiration and stent retriever

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

Group Type: EXPERIMENTAL

Combined contact aspiration/Stent Retriever Technique

Intervention Type: COMBINATION_PRODUCT

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 mechanical thrombectomy alone

Stent retriever mechanical thrombectomy alone for recanalisation

Group Type: ACTIVE_COMPARATOR

Stent retriever technique

Intervention Type: DEVICE

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.

Interventions

Combined contact aspiration/Stent Retriever Technique

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

Intervention Type: COMBINATION_PRODUCT

Stent retriever technique

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hopital Foch

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bertrand Lapergue, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Foch

Michel Piotin, MD

Role: STUDY_CHAIR

Fondation Ophtalmologique de Rothschild

Locations

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

Hôpital Foch

Suresnes, , France

Countries

France

References

Sgreccia A, Desilles JP, Costalat V, Dargazanli C, Bourcier R, Tessier G, Rouchaud A, Saleme S, Spelle L, Caroff J, Marnat G, Barreau X, Clarencon F, Shotar E, Eugene F, Houdart E, Gory B, Zhu F, Labreuche J, Piotin M, Lapergue B, Consoli A; ASTER2 Investigators. Combined Technique for Internal Carotid Artery Terminus or Middle Cerebral Artery Occlusions in the ASTER2 Trial. Stroke. 2024 Feb;55(2):376-384. doi: 10.1161/STROKEAHA.123.045227. Epub 2023 Dec 21.

Reference Type: DERIVED

PMID: 38126181 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34581737 (View on PubMed)

Other Identifiers

2016-A01735-46

Identifier Type: OTHER

Identifier Source: secondary_id

2017014F

Identifier Type: -

Identifier Source: org_study_id