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

NCT03290885 | Completed

• 2 other identifiers: 2017014F2016-A01735-46
• Study Type: interventional
• Target: 408
• Locations: 1 country
• Sites: 11

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

Outcome Measures

Primary Outcomes (1)

• 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)

  24 hours

Secondary Outcomes (13)

• 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

• 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

• Modified Rankin scale (mRs)

  90 days

Study Arms (2)

Combined use of contact aspiration and stent retriever

EXPERIMENTAL

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

Combination Product: Combined contact aspiration/Stent Retriever Technique

Stent retriever mechanical thrombectomy alone

ACTIVE COMPARATOR

Stent retriever mechanical thrombectomy alone for recanalisation

Device: Stent retriever technique

Interventions

Combined contact aspiration/Stent Retriever Technique 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

Combined use of contact aspiration and stent retriever

Stent retriever technique 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.

Stent retriever mechanical thrombectomy alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (11)

CHU Bordeaux

Bordeaux, France

Location

CHU Limoges

Limoges, France

Location

CHU Montpellier

Montpellier, France

Location

CHU Nancy

Nancy, France

Location

CHU Nantes

Nantes, France

Location

Fondation Ophtalmologique Rotschild

Paris, 75019, France

Location

Kremlin-Bicêtre (APHP)

Paris, France

Location

La Pitié-Salpétrière (APHP)

Paris, France

Location

Lariboisière (APHP)

Paris, France

Location

CHU Rennes

Rennes, France

Location

Hôpital Foch

Suresnes, 92150, France

Location

Related Publications (2)

• 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.

  PMID: 38126181 DERIVED

• 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.

  PMID: 34581737 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Bertrand Lapergue, MD

  Hôpital Foch

  PRINCIPAL INVESTIGATOR

• Michel Piotin, MD

  Fondation Ophtalmologique de Rothschild

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: September 25, 2017
• Study Start: October 16, 2017
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: May 26, 2020

Record last verified: 2020-05

Locations

FR (11)