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

Primary Purpose

Acute Ischemic Stroke

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Combined contact aspiration/Stent Retriever Technique
Stent retriever technique
Sponsored by
Hopital Foch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Acute Ischemic Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU Bordeaux
  • CHU Limoges
  • CHU Montpellier
  • CHU Nancy
  • CHU Nantes
  • Fondation Ophtalmologique Rotschild
  • Kremlin-Bicêtre (APHP)
  • La Pitié-Salpétrière (APHP)
  • Lariboisière (APHP)
  • CHU Rennes
  • Hôpital Foch

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Combined use of contact aspiration and stent retriever

Stent retriever mechanical thrombectomy alone

Arm Description

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

Stent retriever mechanical thrombectomy alone for recanalisation

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Rate of successful reperfusion
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 from groin puncture to achieve TICI 2c or better revascularization
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 between groin puncture to clot contact and clot contact to maximum reperfusion
Modified Rankin scale (mRs)
Global disability assessed by overall distribution of mRs at 90-days
Rate of favorable functional independence
Rate of favorable functional independence defined as a mRS 0-2 at 90 days
Rate of excellent functional outcome
Rate of excellent functional outcome defined as a Modified Rankin scale (mRS) 0-1 at 90 days
NIHSS score
Change in NIHSS from baseline to 24 hours (delta NIHSS)
Rate of symptomatic and asymptomatic intracerebral hemorrhage
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
Rate of all-cause mortality
Rate of periprocedural complications
- Rate of periprocedural complications: Occurrence of emboli to new territory (ENT), vasospasm, dissection, or perforation.
Average cost per patient
Average cost per patient with complete recanalization

Full Information

First Posted
September 19, 2017
Last Updated
May 22, 2020
Sponsor
Hopital Foch
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1. Study Identification

Unique Protocol Identification Number
NCT03290885
Brief Title
Combined Use of Contact Aspiration and the Stent Retriever Technique Versus Stent Retriever Alone for Recanalisation in Acute Cerebral Infarction
Acronym
ASTER2
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
October 16, 2017 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
February 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
408 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Combined use of contact aspiration and stent retriever
Arm Type
Experimental
Arm Description
Combined use of contact aspiration and stent retriever mechanical thrombectomy for recanalization
Arm Title
Stent retriever mechanical thrombectomy alone
Arm Type
Active Comparator
Arm Description
Stent retriever mechanical thrombectomy alone for recanalisation
Intervention Type
Combination Product
Intervention Name(s)
Combined contact aspiration/Stent Retriever Technique
Intervention Description
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
Device
Intervention Name(s)
Stent retriever technique
Intervention Description
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.
Primary Outcome Measure Information:
Title
Perfect reperfusion rate
Description
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)
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Rate of successful reperfusion
Description
Rate of successful reperfusion (mTICI 2b/2c/3), and complete reperfusion (mTICI3) at end of endovascular procedure
Time Frame
24 hours
Title
Rate of perfect (mTICI 2c/3), successful reperfusion (mTICI 2b/2c/3), and complete reperfusion (mTICI3) after the frontline strategy
Time Frame
24 hours
Title
Time from groin puncture to achieve TICI 2c or better revascularization
Description
Time from groin puncture to achieve TICI 2c or better revascularization
Time Frame
24 hours
Title
Time between groin puncture to clot contact and clot contact to maximum reperfusion
Description
Time between groin puncture to clot contact and clot contact to maximum reperfusion
Time Frame
24 hours
Title
Modified Rankin scale (mRs)
Description
Global disability assessed by overall distribution of mRs at 90-days
Time Frame
90 days
Title
Rate of favorable functional independence
Description
Rate of favorable functional independence defined as a mRS 0-2 at 90 days
Time Frame
90 days
Title
Rate of excellent functional outcome
Description
Rate of excellent functional outcome defined as a Modified Rankin scale (mRS) 0-1 at 90 days
Time Frame
90 days
Title
NIHSS score
Description
Change in NIHSS from baseline to 24 hours (delta NIHSS)
Time Frame
24 hours
Title
Rate of symptomatic and asymptomatic intracerebral hemorrhage
Description
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).
Time Frame
24 hours
Title
Rate of parenchymal hematoma
Time Frame
90 days
Title
Rate of all-cause mortality
Time Frame
90 days
Title
Rate of periprocedural complications
Description
- Rate of periprocedural complications: Occurrence of emboli to new territory (ENT), vasospasm, dissection, or perforation.
Time Frame
90 days
Title
Average cost per patient
Description
Average cost per patient with complete recanalization
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bertrand Lapergue, MD
Organizational Affiliation
Hôpital Foch
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michel Piotin, MD
Organizational Affiliation
Fondation Ophtalmologique de Rothschild
Official's Role
Study Chair
Facility Information:
Facility Name
CHU Bordeaux
City
Bordeaux
Country
France
Facility Name
CHU Limoges
City
Limoges
Country
France
Facility Name
CHU Montpellier
City
Montpellier
Country
France
Facility Name
CHU Nancy
City
Nancy
Country
France
Facility Name
CHU Nantes
City
Nantes
Country
France
Facility Name
Fondation Ophtalmologique Rotschild
City
Paris
ZIP/Postal Code
75019
Country
France
Facility Name
Kremlin-Bicêtre (APHP)
City
Paris
Country
France
Facility Name
La Pitié-Salpétrière (APHP)
City
Paris
Country
France
Facility Name
Lariboisière (APHP)
City
Paris
Country
France
Facility Name
CHU Rennes
City
Rennes
Country
France
Facility Name
Hôpital Foch
City
Suresnes
ZIP/Postal Code
92150
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
34581737
Citation
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.
Results Reference
derived

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

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