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

May 22, 2020 updated by: Hopital Foch

Combined Use of Contact Aspiration and the Stent Retriever Technique Versus Stent Retriever Alone for Recanalisation in Acute Cerebral Infarction: the Randomized ASTER2 Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
408

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France
        • CHU Bordeaux
      • Limoges, France
        • CHU Limoges
      • Montpellier, France
        • CHU Montpellier
      • Nancy, France
        • CHU Nancy
      • Nantes, France
        • CHU Nantes
      • Paris, France, 75019
        • Fondation Ophtalmologique Rotschild
      • Paris, France
        • Kremlin-Bicêtre (APHP)
      • Paris, France
        • La Pitié-Salpétrière (APHP)
      • Paris, France
        • Lariboisière (APHP)
      • Rennes, France
        • Chu Rennes
      • Suresnes, France, 92150
        • Hopital Foch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
24 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
24 hours
Rate of perfect (mTICI 2c/3), successful reperfusion (mTICI 2b/2c/3), and complete reperfusion (mTICI3) after the frontline strategy
Time Frame: 24 hours
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
24 hours
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
24 hours
Modified Rankin scale (mRs)
Time Frame: 90 days
Global disability assessed by overall distribution of mRs at 90-days
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
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
90 days
NIHSS score
Time Frame: 24 hours
Change in NIHSS from baseline to 24 hours (delta NIHSS)
24 hours
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).
24 hours
Rate of parenchymal hematoma
Time Frame: 90 days
90 days
Rate of all-cause mortality
Time Frame: 90 days
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.
90 days
Average cost per patient
Time Frame: 90 days
Average cost per patient with complete recanalization
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hopital Foch

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Michel Piotin, MD, Fondation ophtalmologique de Rothschild

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 16, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 26, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017014F
  • 2016-A01735-46 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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