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

• ClinicalTrials.gov Identifier: NCT03290885
• Recruitment Status: Completed
• First Posted: September 25, 2017
• Last Update Posted: May 26, 2020
• Sponsor: Hopital Foch
• Information provided by (Responsible Party): Hopital Foch

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Acute Ischemic Stroke	Combination Product: Combined contact aspiration/Stent Retriever Technique; Device: Stent retriever technique	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 408 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Combined Use of Contact Aspiration and the Stent Retriever Technique Versus Stent Retriever Alone for Recanalisation in Acute Cerebral Infarction: the Randomized ASTER2 Study
• Actual Study Start Date: October 16, 2017
• Actual Primary Completion Date: February 28, 2020
• Actual Study Completion Date: February 28, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Combined use of contact aspiration and stent retriever; Combined use of contact aspiration and stent retriever mechanical thrombectomy for recanalization	Combination Product: 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
Active Comparator: Stent retriever mechanical thrombectomy alone; Stent retriever mechanical thrombectomy alone for recanalisation	Device: 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.

Outcome Measures

Primary Outcome Measures :

1. Perfect reperfusion rate [ Time Frame: 24 hours ]
   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)

Secondary Outcome Measures :

1. Rate of successful reperfusion [ Time Frame: 24 hours ]
   Rate of successful reperfusion (mTICI 2b/2c/3), and complete reperfusion (mTICI3) at end of endovascular procedure
2. Rate of perfect (mTICI 2c/3), successful reperfusion (mTICI 2b/2c/3), and complete reperfusion (mTICI3) after the frontline strategy [ Time Frame: 24 hours ]
3. Time from groin puncture to achieve TICI 2c or better revascularization [ Time Frame: 24 hours ]
   Time from groin puncture to achieve TICI 2c or better revascularization
4. Time between groin puncture to clot contact and clot contact to maximum reperfusion [ Time Frame: 24 hours ]
   Time between groin puncture to clot contact and clot contact to maximum reperfusion
5. Modified Rankin scale (mRs) [ Time Frame: 90 days ]
   Global disability assessed by overall distribution of mRs at 90-days
6. Rate of favorable functional independence [ Time Frame: 90 days ]
   Rate of favorable functional independence defined as a mRS 0-2 at 90 days
7. Rate of excellent functional outcome [ Time Frame: 90 days ]
   Rate of excellent functional outcome defined as a Modified Rankin scale (mRS) 0-1 at 90 days
8. NIHSS score [ Time Frame: 24 hours ]
   Change in NIHSS from baseline to 24 hours (delta NIHSS)
9. Rate of symptomatic and asymptomatic intracerebral hemorrhage [ Time Frame: 24 hours ]
   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).
10. Rate of parenchymal hematoma [ Time Frame: 90 days ]
11. Rate of all-cause mortality [ Time Frame: 90 days ]
12. Rate of periprocedural complications [ Time Frame: 90 days ]
    - Rate of periprocedural complications: Occurrence of emboli to new territory (ENT), vasospasm, dissection, or perforation.
13. Average cost per patient [ Time Frame: 90 days ]
    Average cost per patient with complete recanalization

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

France

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, 75019

Kremlin-Bicêtre (APHP)

Paris, France

La Pitié-Salpétrière (APHP)

Paris, France

Lariboisière (APHP)

Paris, France

CHU Rennes

Rennes, France

Hôpital Foch

Suresnes, France, 92150

Sponsors and Collaborators

Hopital Foch

Investigators

• Principal Investigator: Bertrand Lapergue, MD; Hôpital Foch
• Study Chair: Michel Piotin, MD; Fondation Ophtalmologique de Rothschild

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Hopital Foch
• ClinicalTrials.gov Identifier: NCT03290885
• Other Study ID Numbers: 2017014F; 2016-A01735-46 ( Other Identifier: ANSM )
• First Posted: September 25, 2017
• Last Update Posted: May 26, 2020
• Last Verified: May 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Ischemic Stroke; Cerebral Infarction; Infarction; Ischemia; Pathologic Processes; Necrosis; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Infarction; Brain Ischemia