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

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ClinicalTrials.gov Identifier: NCT03290885

Recruitment Status : Recruiting

First Posted : September 25, 2017

Last Update Posted : November 8, 2017

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Sponsor:

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)
Estimated 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
Estimated Primary Completion Date :	February 28, 2020
Estimated 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.

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 :

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 :

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
Rate of perfect (mTICI 2c/3), successful reperfusion (mTICI 2b/2c/3), and complete reperfusion (mTICI3) after the frontline strategy [ Time Frame: 24 hours ]
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
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
Modified Rankin scale (mRs) [ Time Frame: 90 days ]
Global disability assessed by overall distribution of mRs at 90-days
Rate of favorable functional independence [ Time Frame: 90 days ]
Rate of favorable functional independence defined as a mRS 0-2 at 90 days
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
NIHSS score [ Time Frame: 24 hours ]
Change in NIHSS from baseline to 24 hours (delta NIHSS)
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).
Rate of parenchymal hematoma [ Time Frame: 90 days ]
Rate of all-cause mortality [ Time Frame: 90 days ]
Rate of periprocedural complications [ Time Frame: 90 days ]
- Rate of periprocedural complications: Occurrence of emboli to new territory (ENT), vasospasm, dissection, or perforation.
Average cost per patient [ Time Frame: 90 days ]
Average cost per patient with complete recanalization

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03290885

Contacts


Contact: Bertrand Lapergue, MD	+33(0)146257343	b.lapergue@hopital-foch.org

Locations


France
Fondation Ophtalmologique Rotschild	Recruiting
Paris, France, 75019
Contact: Michel PIOTIN, MD +33(0)148036829 mpiotin@fo-rothschild.fr
Principal Investigator: Michel PIOTIN, MD
Hôpital Foch	Recruiting
Suresnes, France, 92150
Contact: Bertrand Lapergue, MD +33(0)1 46 25 73 43 b.lapergue@hopital-foch.org
Principal Investigator: Bertrand Lapergue, MD

Sponsors and Collaborators

Hopital Foch

Investigators


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

More Information


Responsible Party:	Hopital Foch
ClinicalTrials.gov Identifier:	NCT03290885 History of Changes
Other Study ID Numbers:	2017014F 2016-A01735-46 ( Other Identifier: ANSM )
First Posted:	September 25, 2017 Key Record Dates
Last Update Posted:	November 8, 2017
Last Verified:	November 2017


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

Additional relevant MeSH terms:


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

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