Acute Ischemic StrokeASTER2NCT03290885
Combined Use of Contact Aspiration and the Stent Retriever Technique Versus Stent Retriever Alone for Recanalisation in Acute Cerebral Infarction
A study testing Combined contact aspiration/Stent Retriever Technique and Stent retriever technique in people with Acute Ischemic Stroke, run by Hopital Foch at 11 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Combined contact aspiration/Stent Retriever Technique and Stent retriever technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 408 participants
- Where
- 11 sitesFrance
- Study dates
- 16 Oct 2017to 28 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
CHU Bordeaux
Bordeaux
CHU Limoges
Limoges
CHU Montpellier
Montpellier
CHU Nancy
Nancy
CHU Nantes
Nantes
Fondation Ophtalmologique Rotschild
Paris, 75019
Kremlin-Bicêtre (APHP)
Paris
La Pitié-Salpétrière (APHP)
Paris
Lariboisière (APHP)
Paris
CHU Rennes
Rennes
Hôpital Foch
Suresnes, 92150
About this study
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
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
- Being tested
- Combined contact aspiration/Stent Retriever Technique, Stent retriever technique
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined contact aspiration/Stent Retriever TechniqueCombination 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
Stent retriever techniqueDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Combined use of contact aspiration and stent retriever | Experimental | Combined use of contact aspiration and stent retriever mechanical thrombectomy for recanalization Receives: Combination Product: Combined contact aspiration/Stent Retriever Technique |
| Stent retriever mechanical thrombectomy alone | Active comparator | Stent retriever mechanical thrombectomy alone for recanalisation Receives: Device: Stent retriever technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 24 hours
Secondary outcomes (13)
Rate of successful reperfusion
Rate of successful reperfusion (mTICI 2b/2c/3), and complete reperfusion (mTICI3) at end of endovascular procedure
Measured: 24 hours
Rate of perfect (mTICI 2c/3), successful reperfusion (mTICI 2b/2c/3), and complete reperfusion (mTICI3) after the frontline strategy
Measured: 24 hours
Time from groin puncture to achieve TICI 2c or better revascularization
Time from groin puncture to achieve TICI 2c or better revascularization
Measured: 24 hours
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
Measured: 24 hours
Modified Rankin scale (mRs)
Global disability assessed by overall distribution of mRs at 90-days
Measured: 90 days
Rate of favorable functional independence
Rate of favorable functional independence defined as a mRS 0-2 at 90 days
Measured: 90 days
Rate of excellent functional outcome
Rate of excellent functional outcome defined as a Modified Rankin scale (mRS) 0-1 at 90 days
Measured: 90 days
NIHSS score
Change in NIHSS from baseline to 24 hours (delta NIHSS)
Measured: 24 hours
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).
Measured: 24 hours
Rate of parenchymal hematoma
Measured: 90 days
Rate of all-cause mortality
Measured: 90 days
Rate of periprocedural complications
- Rate of periprocedural complications: Occurrence of emboli to new territory (ENT), vasospasm, dissection, or perforation.
Measured: 90 days
Average cost per patient
Average cost per patient with complete recanalization
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start16 Oct 2017
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 408 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bertrand Lapergue, MD, Principal investigator, Hôpital FochMichel Piotin, MD, Study chair, Fondation Ophtalmologique de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03290885
- Sponsor's protocol ID
- 2017014F
- Other IDs
- 2016-A01735-46
- Acronym
- ASTER2
- Status last verified
- May 2020
- First submitted
- 19 Sep 2017
- Last updated
- 26 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38126181Lapergue 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.
PubMed 34581737
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03290885
- Acronym / sponsor ID
- ASTER2 / 2017014F
- Conditions
- Acute Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 408 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 25 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined use of contact aspiration and stent retriever | Experimental | Combination Product: Combined contact aspiration/Stent Retriever TechniqueCombined use of contact aspiration and stent retriever mechanical thrombectomy for recanalization |
| Stent retriever mechanical thrombectomy alone | Active comparator | Device: Stent retriever techniqueStent retriever mechanical thrombectomy alone for recanalisation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined contact aspiration/Stent Retriever TechniqueCombined 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 | Combination product | Combined use of contact aspiration and stent retriever |
| Stent retriever techniqueThe 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. | Device | Stent retriever mechanical thrombectomy alone |
Primary outcome
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)
13 secondary outcomes
Rate of successful reperfusion
Time frame: 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
Time from groin puncture to achieve TICI 2c or better revascularization
Time frame: 24 hours
Time between groin puncture to clot contact and clot contact to maximum reperfusion
Time frame: 24 hours
Modified Rankin scale (mRs)
Time frame: 90 days
Rate of favorable functional independence
Time frame: 90 days
Rate of excellent functional outcome
Time frame: 90 days
NIHSS score
Time frame: 24 hours
Rate of symptomatic and asymptomatic intracerebral hemorrhage
Time frame: 24 hours
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
Average cost per patient
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2020.
- Derived from this study: PubMed 38126181Sgreccia 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.
- Derived from this study: PubMed 34581737Lapergue 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bertrand Lapergue, MD principal investigator
Hôpital Foch
Michel Piotin, MD study chair
Fondation Ophtalmologique de Rothschild
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined contact aspiration/Stent Retriever Technique and Stent retriever technique in people with Acute Ischemic Stroke, run by Hopital Foch at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perfect reperfusion rate (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03290885, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2020.