AzTrials
AzTrials

StrokeLASTENCT03811769

Large Stroke Therapy Evaluation

A study testing Best Medical Therapy and Mechanical Thrombectomy in people with Stroke, run by University Hospital, Montpellier at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

Stroke represents the fourth leading cause of death in industrialized nations, after heart disease, cancer, and chronic lower respiratory disease. The overall burden of stroke will rise dramatically in the next 20 years due to an ageing population. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
What is being tested?
Best Medical Therapy and Mechanical Thrombectomy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
335 participants
Where
1 siteFrance
Study dates
7 Apr 2019to 24 Aug 2023
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

  • Subject is ≥ 18 years old at inclusion (no upper age limit)
  • Clinical signs consistent with acute ischemic stroke with symptoms onset or TLKW ≤ 6.5 hours from randomization, or with negative FLAIR on MRI if TLSW is unknown, with treatment started within 7 hours.
  • Proven Large Ischemic Core defined as: ASPECT Score ≤ 5 on non-contrast CT or DWI-MRI, and in patients ≥ 80 years: ASPECT = 3 to 5 on non-contrast CT or DWI-MRI
  • Proved anterior circulation intracranial large vessel occlusion on CTA or MRA (intracranial ICA, M1, M1-M2). The MCA - M1 segment is defined as the first branch of the intracranial ICA which courses horizontally from its branching point off the ICA through the Sylvian fissure up to the first bifurcation distal to the lenticulo-striate arteries, in the Sylvian fissure. M2 is defined as the portions of the MCA distal to the first bifurcation or trifurcation, but prior to the second bifurcation.
  • Patient or patient's representative has received information about the study and has signed and dated the appropriate Informed Consent Form
  • Selection imaging performed ≤ 3 hours before randomization
Show all 11Show fewer
  • Anticipated possibility to start the procedure (arterial access) within 30 minutes after randomization
  • Pre stroke mRS ≤ 1
  • Subjects receiving antiaggregant and/or anticoagulant agents (at any mode of administration) within the last 24 hours from screening are eligible for participation.
  • NIHSS > 6
  • For patients for whom thrombolytic therapy, such as IV t-PA, is indicated, such treatment is initiated as soon as possible and within the accepted clinical guidelines as measured from stroke symptom onset.

Who cannot join

  • Known absence of vascular access.
  • Known contrast or endovascular product life-threatening allergy.
  • Female who is known to be pregnant or lactating at time of admission
  • Patient presents severe or fatal co-morbidities or life expectancy under 6 months that will likely interfere with the improvement or follow-up or that will render the procedure unlikely to benefit the patient.
  • Patient unable to present or be available for follow-up.
  • Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations.
Show all 26Show fewer
  • Evidence of vessel recanalization prior to randomization.
  • Seizures at stroke onset if it makes the diagnosis of stroke doubtful and precludes obtaining an accurate baseline NIHSS assessment.
  • Current participation in another investigational drug study.
  • Suspicion of aortic dissection based on medical history, clinical evaluation or/and imaging.
  • Major patients under guardianship.
  • Blood glucose < 50 mg/dL or > 400 mg/dL
  • Cr > 4.0 mg/dL, unless the patient is on dialysis
  • Platelet count < 50000/uL
  • INR > 3.0 or PTT > 3 times upper limit of normal (ULN)
  • Imaging Exclusion Criteria:
  • Isolated proximal cervical ICA occlusions or proximal cervical ICA occlusions with MCA-M1 or intracranial ICA occlusion requiring stent placement, and isolated M2 occlusions on the pre-randomization neuro-imaging
  • Evidence of intracranial hemorrhage on CT/MRI
  • Excessive tortuosity of cervical vessels on CTA/MRA that would likely result in unstable access platform
  • High Suspicion of underlying intracranial stenosis on CTA/MRA/DSA
  • Suspected cerebral vascular disease (e.g. vasculitis) based on medical history and CTA/MRA/DSA
  • Presumed calcified Embolus or Intracranial Stenosis decompensation
  • Intracranial stent implanted in the same vascular territory that would preclude the safe deployment/removal of the stentriever device
  • Occlusions in multiple vascular territories (e.g.: bilateral anterior circulation, or anterior circulation/vertebrobasilar system) confirmed on CTA/MRA/DSA.
  • Significant mass effect with midline shift as confirmed on CT/MRI
  • Any ipsilateral cervical ICA lesion (Tandem), that requires stent placement

Trial locations and contacts

1 site in 1 country.

France1 site
  • Hopital Gui De Chauliac

    Montpellier, 34295

Other trials in France

About this study

Official title: Evaluation of Acute Mechanical Revascularisation in Large Stroke (ASPECTS 0-5) With Large Vessel Occlusion Within 7 Hours After Stroke Onset or Last Known Well

Stroke represents the fourth leading cause of death in industrialized nations, after heart disease, cancer, and chronic lower respiratory disease. The overall burden of stroke will rise dramatically in the next 20 years due to an ageing population. Approximately one-quarter of the patients suffering a stroke die within one year after the initial event and stroke is a leading cause of serious long-term disability. Acute ischemic stroke (AIS) due to large vessel occlusion (LVO) is a potentially devastating event, with a poor prognosis in the absence of timely revascularization. Whether in patients with large anterior circulation stroke, direct mechanical intervention is equally effective, superior or inferior to bridging thrombolysis remains a matter of debate.

Thus, this procedure, is now the recommended standard of care for selective patients with LVO in the anterior circulation. When performed with newer generation devices (mainly stent retrievers), more stringent imaging selection criteria and more efficient workflow than in previous trials, significantly reduces disability rates after AIS caused by LVO in the anterior circulation.

The STAIR (Stroke Treatment Academic Industry Roundtable) meeting aims to advance acute stroke therapy development through collaboration between academia, industry, and regulatory institutions. In pursuit of this goal and building on the available level I evidence of benefit from endovascular therapy (EVT) in large vessel occlusion stroke, STAIR IX consensus recommendations were developed that outline priorities for future research in EVT.

Read the detailed description

The LASTE hypothesis is that patient harbouring a large ischemic core stroke at presentation, may still benefit from mechanical thrombectomy, given the very poor natural history of patient managed by a standalone medical therapy.

The threshold of ASPECTS 5 to set a benefit for treatment was inspired by initial large medical trials using IV t-PA25-27 (Samurai-CT ALBERTA Score IV cohort). In the paradigm of acute and complete reperfusion, radiographic infarct stroke volume may be partially reversible and thus the resulting final infarct may be smaller compared to the one in non-re-perfused patients who will consequently have poorer clinical outcomes. By now, large core patients defined as ASPECTS 0-5 were excluded from most randomized clinical trials resulting in a lack of unequivocal evidence of benefit in this patient population.

Analyses of several prospective cohorts suggest signals of benefit in favor of thrombectomy in patients with large baseline core. In the prospective cohort ETIS, LAPERGUE et al reported a rate of good outcome of 34% in the subgroup of patient with ASPECT 4-5. In the prospective cohort analysis RECOST, a mean mRS score of 34% in a group of patient presenting ASPECT 0-5 treated with mechanical thrombectomy, versus 9% of good outcome in the medical group, suggesting a benefit to treat LVO harbouring a large core. The strongest argument in favor of benefit of EVT even in patients with large core is provided by the six completed randomized endovascular stroke trials. These trials did prove that Combined Approach Mechanical + IV t-PA, is superior to standalone IV lytics, mRs score ≤ 2 ranging from 33% and up to 72%, but Large Core Infarction were largely excluded. Nonetheless a pooled analysis of these trials revealed that a minority of patients with large baseline core were still randomized. In MR CLEAN study, despite no exclusion criteria defined in the initial protocol, the median ASPECT score of the cohort was 9 out of 10. In SWIFT-PRIME study, the mean ASPECT score of the cohort was 7, and in REVASCAT study it was 6.8.

The LASTE protocol "Large Stroke Therapy Evaluation" aims to study the efficacy and safety of mechanical thrombectomy in the acute phase of cerebral infarction less than 7 hours for patients with a large volume of necrosis defined by a score ASPECT from 0 to 5. The patients will be followed 6 months after the stroke.

Conditions
Stroke
Being tested
Best Medical Therapy, Mechanical Thrombectomy
Keywords
Mechanical thrombectomy, Stroke, Proximal intracranial arterial occlusions, Large vessel occlusion
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Best Medical TherapyOther

    The administration of medications is at the treating physician's discretion (for example intravenous fibrinolysis, anticoagulants or antiplatelet) according to local standards of care but may NOT include any intra-arterial therapies.

  • Mechanical ThrombectomyProcedure or surgery

    MT in the Experimental Arm can be performed with any thrombectomy (CE labeled) device usually used at study site. For the subjects randomized to the MT plus BMT arm start of treatment is defined as the date and time of groin puncture (arterial access).

Study groups in NCT03811769
Study groupRoleWhat they receive
Best Medical Therapy (BMT)OtherBest treatment medical probably associated to the rescue endovascular treatment in case of neurological deterioration
Receives: Other: Best Medical Therapy
Mechanical Thrombectomy (MT)OtherEndovascular treatment (thrombectomy) associated with the best medical treatment
Receives: Procedure: Mechanical Thrombectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of patient's condition

    Shift on the mRS at 90 days in experimental group vs the control group

    Measured: 3 months

Secondary outcomes (8)
  1. Evaluation of patient's condition

    The degree of disability at 180 days (shift on the mRS combining scores of 5 and 6)

    Measured: 6 months

  2. Evaluation of good functional outcome

    Rate of patients with a good functional outcome at 90 days and 180 days, defined as mRS 0-2

    Measured: 3 and 6 months

  3. Evaluation of functional outcome

    Rate of patients with a favorable outcome at 90 and 180 days, defined as mRS 0-3

    Measured: 3 and 6 months

  4. Evaluation of treatment effect

    Distribution of utility weighted mRS (UW mRS) at 90 and 180 days

    Measured: 3 and 6 months

  5. Evaluation of quality of life

    Quality of life at 90 and 180 days assessed by EuroQol/EQ-5D

    Measured: 3 and 6 months

  6. Evaluation of decompressive condition

    Rate of patients with secondary decompressive craniectomy within 7 days

    Measured: 7 days

  7. Evaluation of medical response

    Rate of patients with "early good response" at Day 5-7/Discharge (whichever is earlier), defined as a NIHSS drop of ≥ 8 points from baseline or NIHSS score 0 or 1

    Measured: Day 5-7 or discharge, whichever is earlier

  8. Evaluation of medical condition

    Change in infarct volumes on CT or MRI from baseline to 24 hours post randomization

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2019
  2. Study start7 Apr 2019
  3. Primary completion26 Apr 2023
  4. Study completion24 Aug 2023

Why it stopped: Although the planned sample size was 450, enrollment was halted early following an unplanned interim analysis recommended by the Data Safety Monitoring Board because results favoring thrombectomy were reported from other similar trials.

Resources

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
None (open label)
Enrolment
335 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03811769
Sponsor's protocol ID
RECHMPL18_0173
Acronym
LASTE
Status last verified
Sep 2025
First submitted
10 Jan 2019
Last updated
29 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Cody JT. Cross-reactivity of amphetamine analogues with Roche Abuscreen radioimmunoassay reagents. J Anal Toxicol. 1990 Jan-Feb;14(1):50-3. doi: 10.1093/jat/14.1.50.

    PubMed 2314063
  • Costalat V, Jovin TG, Albucher JF, Cognard C, Henon H, Nouri N, Gory B, Richard S, Marnat G, Sibon I, Di Maria F, Annan M, Boulouis G, Cardona P, Obadia M, Piotin M, Bourcier R, Guillon B, Godard S, Pasco-Papon A, Eker OF, Cho TH, Turc G, Naggara O, Velasco S, Lamy M, Clarencon F, Alamowitch S, Renu A, Suissa L, Brunel H, Gentric JC, Timsit S, Lamy C, Chivot C, Macian-Montoro F, Mounayer C, Ozkul-Wermester O, Papagiannaki C, Wolff V, Pop R, Ferrier A, Chabert E, Ricolfi F, Bejot Y, Lopez-Cancio E, Vega P, Spelle L, Denier C, Millan M, Arenillas JF, Mazighi M, Houdart E, Del Mar Freijo M, Duhamel A, Sanossian N, Liebeskind DS, Labreuche J, Lapergue B, Arquizan C; LASTE Trial Investigators. Trial of Thrombectomy for Stroke with a Large Infarct of Unrestricted Size. N Engl J Med. 2024 May 9;390(18):1677-1689. doi: 10.1056/NEJMoa2314063.

    PubMed 38718358
  • Lapergue B, Arquizan C, Albucher JF, Cognard C, Henon H, Nouri N, Gory B, Richard S, Marnat G, Sibon I, Di Maria F, Annan M, Boulouis G, Cardona P, Labreuche J, Costalat V, Jovin TG; LASTE Trial Investigators. Endovascular Thrombectomy in Patients With Largest Baseline Infarcts (ASPECTS 0-2): An Ancillary Analysis of the LASTE Trial. Stroke. 2026 Jun;57(6):1504-1512. doi: 10.1161/STROKEAHA.125.054161. Epub 2026 Apr 14.

    PubMed 41979451
  • Gerschenfeld G, Lapergue B, Labreuche J, Albucher JF, Cognard C, Henon H, Nouri N, Richard S, Gory B, Sibon I, Marnat G, Van Dokkum L, Liebeskind DS, Jovin TG, Costalat V, Alamowitch S, Arquizan C; LASTE Trial Investigators. Efficacy and safety of bridging therapy and thrombectomy alone in patients with large infarcts of unrestricted size: LASTE trial post hoc analysis. J Neurointerv Surg. 2026 Mar 6:jnis-2025-024872. doi: 10.1136/jnis-2025-024872. Online ahead of print.

    PubMed 41791871
  • Costalat V, Lapergue B, Albucher JF, Labreuche J, Henon H, Gory B, Sibon I, Boulouis G, Cognard C, Nouri N, Richard S, Marnat G, Di Maria F, Annan M, Duhamel A, Cagnazzo F, Jovin T, Arquizan C; LASTE Trial Investigators. Evaluation of acute mechanical revascularization in large stroke (ASPECTS ⩽5) and large vessel occlusion within 7 h of last-seen-well: The LASTE multicenter, randomized, clinical trial protocol. Int J Stroke. 2024 Jan;19(1):114-119. doi: 10.1177/17474930231191033. Epub 2023 Jul 31.

    PubMed 37462028

Questions about this trial

What is this clinical trial studying?

A study testing Best Medical Therapy and Mechanical Thrombectomy in people with Stroke, run by University Hospital, Montpellier at 1 site 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 11 inclusion and 26 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: stopped early, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 was stopped early (reason given: Although the planned sample size was 450, enrollment was halted early following an unplanned interim analysis recommended by the Data Safety Monitoring Board because results favoring thrombectomy were reported from other similar trials.). Results are not available in the source record.

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?

Evaluation of patient's condition (time frame: 3 months). 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 NCT03811769, which also lists 5 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 29 Sep 2025; AzTrials last refreshed its copy on 27 Oct 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in