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Ischemic StrokeAMETIS 2NCT07235514

Anesthesia Management in Endovascular Therapy for Ischemic Stroke - 2

A study testing General Anesthesia and Procedural sedation in people with Ischemic Stroke and Anterior Cerebral Circulation, run by University Hospital, Clermont-Ferrand at 16 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The goal of this clinical trial is to learn what is the best anesthetic management in participants with severe stroke that require a medical intervention called mechanical thrombectomy (MT) done to open the occluded brain vessel. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
General Anesthesia and Procedural sedation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
958 participants
Where
16 sitesFrance
Study dates
24 Mar 2026to 24 Jun 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

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 years
  • Acute ischemic stroke with an occlusion of the intracranial internal carotid artery and/or the proximal middle cerebral artery (M1-M2) with or without association of extracranial occlusion of the cervical internal carotid artery (tandem lesion)
  • Eligible for mechanical thrombectomy according to international guidelines
  • Informed and signed consent of patient, or if he is unable to consent the consent of patient's relative or emergency procedure in the absence of relative
  • National health insurance

Who cannot join

  • Coma or altered vigilance defined as a score ≥ 2 on the level of consciousness 1A subscale of the NIHSS
  • Premorbid disability defined as a mRS > 2
  • Posterior circulation stroke
  • Associated cerebral hemorrhage
  • Stroke complicating another acute illness or postoperative stroke
  • Emesis at arrival in angiosuite
Show all 9Show fewer
  • Allergy to anesthetic medication
  • Pregnant or breast-feeding women
  • Adult under the protection of the law

Trial locations and contacts

16 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Lise Laclautre contact

334.73.754.963

promo_interne_drci@chu-clermontferrand.fr

16 sites in 1 country

France16 sites, 13 recruiting

  • Le Centre Hospitalier Universitaire d'Angers

    Angers, 49933

    Active, not recruiting

  • Le Centre Hospitalier Universitaire Morvan de Brest de Brest

    Brest, 29200

    Lise Laclautre, 334.73.754.963, promo_interne_drci@chu-clermontferrand.fr

    Anaïs Caillard

    Not yet recruiting

  • CHU de Clermont-Ferrand

    Clermont-Ferrand

    Lise Laclautre, 0473754963, promo_interne_drci@chu-clermontferrand.fr

    Russell Chabanne

    Recruiting

  • Le centre hospitalier universitaire de Lille

    Lille, 59000

    Lise Laclautre, 334.73.754.963, promo_interne_drci@chu-clermontferrand.fr

    Pierre Boussemart

    Recruiting

  • Les Hospices Civils de Lyon

    Lyon, 69229

    Lise Laclautre, 334.73.754.963, promo_interne_drci@chu-clermontferrand.fr

    Baptiste Balança

    Recruiting

  • L'Assistance Publique - Hôpitaux de Marseille

    Marseille

    Lise Laclautre, 334.73.754.963, promo_interne_drci@chu-clermontferrand.fr

    Billal Graouch

    Recruiting

  • Le centre hospitalier universitaire de Montpellier

    Montpellier, 34295

    Lise Laclautre, 334.73.754.963, promo_interne_drci@chu-clermontferrand.fr

    Louis Delamarre

    Not yet recruiting

  • Le Centre Hospitalier Universitaire de Nantes

    Nantes, 44093

    Lise Laclautre, 334.73.754.963, promo_interne_drci@chu-clermontferrand.fr

    Xavier Ambrosi

    Recruiting

  • L'Assistance Publique - Hôpitaux de Paris

    Paris, 75610

    Lise Laclautre, 334.73.754.963, promo_interne_drci@chu-clermontferrand.fr

    Vincent Degos

    Recruiting

  • Le Centre Hospitalier Universitaire de La Réunion

    Saint-Denis, 97400

    Lise Laclautre, 334.73.754.963, promo_interne_drci@chu-clermontferrand.fr

    David Couret

    Not yet recruiting

  • Le Centre Hospitalier Universitaire de Saint-Etienne

    Saint-Etienne, 42055

    Lise Laclautre, 334.73.754.963, promo_interne_drci@chu-clermontferrand.fr

    Serge Molliex

    Not yet recruiting

  • Le Centre Hospitalier Universitaire de Strasbourg

    Strasbourg, 67200

    Active, not recruiting

  • L'hôpital Foch

    Suresnes, 92151

    Lise Laclautre, 334.73.754.963, promo_interne_drci@chu-clermontferrand.fr

    Morgan Le Guen

    Not yet recruiting

  • Le Centre Hospitalier Universitaire de Bordeaux

    Talence, 33404

    Active, not recruiting

  • Le Centre Hospitalier Universitaire de Toulouse

    Toulouse, 31059

    Lise Laclautre, 334.73.754.963, promo_interne_drci@chu-clermontferrand.fr

    Pierre Goudy

    Recruiting

  • Le Centre Hospitalier Universitaire de Tours

    Tours, 37044

    Lise Laclautre, 334.73.754.963, promo_interne_drci@chu-clermontferrand.fr

    Marc Laffon

    Not yet recruiting

Other trials in France

About this study

Official title: General Anesthesia Versus Procedural Sedation in Endovascular Therapy for Anterior Circulation Large Vessel Occlusion Stroke: A Multicenter Prospective Randomized Trial

The goal of this clinical trial is to learn what is the best anesthetic management in participants with severe stroke that require a medical intervention called mechanical thrombectomy (MT) done to open the occluded brain vessel.

The main question it aims to answer is:

Read more
  • Is general anesthesia (GA) better than procedural sedation (PS) for improving functional performance and decrease dependance in daily life 3 months after stroke?

GA (a non-arousable state induced by anesthetic medications that require respiratory assistance) or PS (a state of reduced arousal induced by lesser dose of anesthetic medications that do not require respiratory assistance) are both used for MT. GA enables strict immobility that could facilitate the conduct of MT but lessen blood pressure and blood flow in the brain. PS provides less drop in blood pressure but MT could be more difficult due to possible movement and breathing may be decreased.

Researchers will compare GA with PS to see which one is better for MT success and for the functional consequences of stroke.

Participants will be treated with GA or PS for the intervention of MT and will be followed by researchers during their hospital stay and asked by a telephone interview how is their functional status 3 months after stroke.

Read the detailed description

Mechanical thrombectomy (MT) has significantly improved the outcome of anterior circulation large vessel occlusion stroke. The MT procedure could require management by a dedicated anesthesia team to ensure safety and immobility of these frail patients, in order to quickly restore cerebral perfusion and prevent procedural complications. The anesthetic strategy (general anesthesia with tracheal intubation (GA) or procedural sedation with spontaneous ventilation (PS)) can impact the conduct of the procedure and influence the functional outcome. GA ensures immobility and airway control, but can alter blood pressure (BP). PS provides better control of BP but may be associated with respiratory failure and movements that could interfere with intra-arterial navigation.

Three European single-center randomized controlled trials (RCTs) found no difference between GA and PS for their respective primary endpoints. These three trials were pooled in an individual patient data meta-analysis that evaluated functional outcome (modified Rankin Scale mRS) at 3 months as the primary endpoint. 368 patients were included, and GA was associated with a better functional outcome (mean mRS score was 2.8 (95% CI, 2.5-3.1) in the GA group vs. 3.2 (95% CI, 3.0-3.5) in the PS group (difference, 0.43 [95% CI, 0.03-0.83])). The main limitations of this trial were 1) the small sample size (3 small single-center trials), 2/ a possible center effect with over-representation of one trial on the primary endpoint, and 3/ a highly selected population (exclusion of less severe patients (NIHSS<10), stroke presentation > 8 hours and wake up stroke).

Two French multicenter RCTs have recently been published. The GASS trial included 345 patients in four centers with dedicated GA and PS protocols. There was no difference in the primary endpoint, which was functional independence (mRS 0 to 2) at three months (36% for PS vs. 38% for GA (RR, 0.91 [95% CI, 0.69 to 1.19], p = 0.47)). The AMETIS trial included 273 patients in 10 centers with no specified GA or PS protocol. There was no difference in the primary endpoint, which was a composite of functional independence at 3 months and absence of any peri-procedural and medical complications during the first 7 days. The median mRS was 3 (2-5) under GA vs. 3 (2-4) under PS; RR 0.80 [95% CI: 0.53 to 1.22]. GA was strongly associated with the occurrence of arterial hypotension (87.4% vs. 44.9% in the PS group).

However, 1) these multicenter trials had relatively small sample sizes, 2) the time of assessment of the primary outcome measure was highly variable in GASS, and 3) in AMETIS, the BP targets in the GA group were not met and there was heterogeneity in drug management under PS and GA.

These contradictory results reveal a persistent clinical equipoise regarding this important issue.

The AMETIS-2 trial will evaluate almost every patient with anterior circulation large vessel occlusion stroke eligible for MT in different French comprehensive stroke centers.

The trial protocol for PS and GA will use dedicated anesthetic and hemodynamic management protocols.

The primary outcome measure will use an ordinal shift analysis of the mRS score evaluated at 3 months as the primary endpoint.

To extend the effect analysis, functional independence, cognitive and quality of life assessment will be evaluated as secondary endpoints at 3 months.

We therefore hypothesize that, with a dedicated anesthetic protocol and strict hemodynamic control, GA will lead to a better long-term functional outcome after stroke.

Being tested
General Anesthesia, Procedural sedation
Keywords
Ischemic stroke, anterior circulation, mechanical thrombectomy, anesthetic strategy, general anesthesia, procedural sedation, functional outcome, large vessel occlusion stroke
Medical subject headings
Ischemic Stroke

What participants receive

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

  • General AnesthesiaProcedure or surgery

    Also called GA

    In the general anesthesia (GA) group with tracheal intubation : Clinical target: unarousable state Standard preoxygenation, • Rapid sequence induction of GA will use intravenous Etomidate (0.2-0.3mg/Kg) or Ketamine (1-2mg/Kg) and Succinylcholine (1mg/Kg) or Rocuronium (1.2 mg/Kg) • Maintenance of GA will use intravenous Propofol (brain tissue target controlled infusion up to 4.0 µg/mL or up to 5.0 mg/kg/hr) or Sevoflurane (end-tidal concentration up to 2% (EtSevo)) and intravenous Remifentanil (brain tissue target controlled infusion up to 4.0 ng/mL) Movement despite unarousable state: NMBA as needed

  • Procedural sedationProcedure or surgery

    Also called PS

    In the procedural sedation group with spontaneous ventilation :

    Clinical target: alert and "confortable" i.e. minimal to moderate sedation level

    • Subcutaneous local anesthesia with Lidocaine 10mg/mL (maximum 10mL)
    • Intravenous Remifentanil as necessary to achieve the sedation clinical target (brain tissue target controlled infusion up to 2.0 ng/mL). Propofol could be added as necessary (brain tissue target controlled infusion up to 3.0 µg/mL or 2.0 mg/kg/hr).

    The lightest sedation level allowing the intervention has to be sought.

Study groups in NCT07235514
Study groupRoleWhat they receive
General anesthesiaExperimentalGeneral anesthesia with intubation and mechanical ventilation: ECG, SpO2 and BP. BP will be measured every 2 minutes Hyperglycemia (>180mg/dL) and hypoglycemia (<60mg/dL) should be treated (outside of the protocol) Systolic BP: 150 - 180mmHg with Diastolic BP < 105mmHg Norepinephrine tartrate infusion or Nicardipine on a peripheral intravenous line or on a 3-way venous extender, as necessary EtCO2 35 - 45mmHg SpO2 above 94 %. Glycemia as needed End of procedure: Anesthesia will be immediately stopped and extubation should not be delayed. After the intervention, patients are transferred to the post anesthesia care unit and are then admitted to the stroke unit First 24 hours: SBP<180mmHg, DBP<110mmHg and MAP>65mmHg, SpO2 > 94 %, temperature < 38°C, blood glucose 60 - 180mg/dL. Other aspects of monitoring are not modified by the protocol. 24-48h outside of the protocol: non-contrast brain CT or a brain MRI
Receives: Procedure: General Anesthesia
Procedural sedationExperimentalProcedural sedation with spontaneous ventilation: ECG, SpO2 and BP. BP will be measured every 2 minutes Hyperglycemia (>180mg/dL) and hypoglycemia (<60mg/dL) should be treated (outside of the protocol) Systolic BP: 150 - 180mmHg with Diastolic BP < 105mmHg Norepinephrine tartrate infusion or Nicardipine on a peripheral intravenous line or on a 3-way venous extender, as necessary Breathing face mask: EtCO2 and oxygen as necessary SpO2 above 94 %. Glycemia as needed End of procedure: Procedural sedation will be immediately stopped. After the intervention, patients are transferred to the post anesthesia care unit and are then admitted to the stroke unit First 24 hours: SBP<180mmHg, DBP<110mmHg and MAP>65mmHg, SpO2 > 94 %, temperature < 38°C, blood glucose 60 - 180mg/dL. Other aspects of monitoring are not modified by the protocol. 24-48h outside of the protocol: non-contrast brain CT or a brain MRI
Receives: Procedure: Procedural sedation

What is being measured

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

  1. modified Rankin Scale

    modified Rankin Scale, that range from 0 to 6: 0, no neurologic deficit; 1, no clinically significant disability; 2, slight disability; 3, moderate disability requiring some help; 4, moderately severe disability; 5, severe disability; 6, death

    > measured centrally by a blinded evaluator

    Measured: Day 90 after the stroke

Secondary outcomes (21)

  1. Functional independence = key secondary outcome

    Functional independence defined as a score of 0-2 on the rating of the modified Rankin Scale measured centrally by a blinded evaluator. This will be analyzed as a dichotomized measure

    Measured: Day 90 after the stroke

  2. Modified Treatment in Cerebral Infarction scale at the end of thrombectomy (mTICI).

    To assessed efficacy of GA vs PS

    Measured: At day 1 (end of the thrombectomy procedure)

  3. Good quality of reperfusion defined as a mTICI score of 2b-3

    To assessed efficacy of GA vs PS

    Measured: At day 1 (end of the thrombectomy procedure)

  4. Excellent quality of reperfusion defined as a mTICI score of 2c-3

    To assessed efficacy of GA vs PS

    Measured: At day 1 (end of the thrombectomy procedure)

  5. National Institute of Health Stroke Scale (NIHSS)

    To assessed efficacy of GA vs PS

    Measured: At day 1 after the thrombectomy procedure

  6. National Institute of Health Stroke Scale (NIHSS)

    To assessed efficacy of GA vs PS

    Measured: At day 7 after the thrombectomy procedure

  7. Length of stay in stroke-unit and hospital

    To assessed efficacy of GA vs PS

    Measured: At day 90 after the thrombectomy procedure

  8. moderate recovery defined as a score of 0-3 on the rating of the modified Rankin Scale

    To assessed efficacy of GA vs PS

    Measured: At day 90 after the thrombectomy procedure

  9. Utility-weighted modified Rankin scale

    To assessed efficacy of GA vs PS

    Measured: At day 90 after the thrombectomy procedure

  10. Barthel index

    To assessed efficacy of GA vs PS

    Measured: At day 90 after the thrombectomy procedure

  11. Montreal Cognitive Assessment (MOCA)

    To assessed efficacy of GA vs PS

    Measured: At day 90 after the thrombectomy procedure

  12. Stroke Specific Quality Of Life scale (SSQOL)

    To assessed efficacy of GA vs PS

    Measured: At day 90 after the thrombectomy procedure

  13. Per-interventional arterial dissection or perforation defined as a flow-limiting tear or flap in the arterial wall or arterial extravasation of contrast media

    To assessed safety of GA vs PS

    Measured: At the end of the thrombectomy procedure

  14. Per-interventional embolization in another territory defined as a new (not present on the first angiogram) arterial occlusion outside of the middle cerebral artery territory

    To assessed safety of GA vs PS

    Measured: At the end of the thrombectomy procedure

  15. Procedural hypotension, hypertension, blood pressure variability, hypoxemia and aspiration (Yes or No)

    To assessed safety of GA vs PS

    Measured: At the end of the thrombectomy procedure

  16. Hemodynamic protocol adherence

    To assessed safety of GA vs PS

    Measured: At day 1 after the thrombectomy procedure

  17. Post-interventional groin hematoma defined as an accumulation of blood at the puncture site requiring evacuation, transfusion, or extended hospital stay

    To assessed safety of GA vs PS

    Measured: At day 7 after the thrombectomy procedure

  18. Intracranial hemorrhage

    To assessed safety of GA vs PS

    Measured: At day 1 after the thrombectomy procedure

  19. medical complications (could be evaluated before day 7 if the patient quit the hospital)

    To assessed safety of GA vs PS

    Measured: At day 7 after the thrombectomy procedure

  20. Mortality

    To assessed safety of GA vs PS

    Measured: At day 7 after the thrombectomy procedure

  21. Mortality

    To assessed safety of GA vs PS

    Measured: At day 90 after the thrombectomy procedure

Timeline

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

  1. First posted19 Nov 2025
  2. Study start24 Mar 2026
  3. Primary completion24 Jun 2029 (estimated)
  4. Study completion24 Jun 2029 (estimated)

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective Randomized Open Blinded Endpoint trial (PROBE design)
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
958 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07235514
Sponsor's protocol ID
PHRC 2024 CHABANNE
Other IDs
2025-A00169-40
Acronym
AMETIS 2
Status last verified
Aug 2026
First submitted
2 Oct 2025
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD that underlie results in a publication can be made available upon specific request from investigators.

Publications

  • Schonenberger S, Henden PL, Simonsen CZ, Uhlmann L, Klose C, Pfaff JAR, Yoo AJ, Sorensen LH, Ringleb PA, Wick W, Kieser M, Mohlenbruch MA, Rasmussen M, Rentzos A, Bosel J. Association of General Anesthesia vs Procedural Sedation With Functional Outcome Among Patients With Acute Ischemic Stroke Undergoing Thrombectomy: A Systematic Review and Meta-analysis. JAMA. 2019 Oct 1;322(13):1283-1293. doi: 10.1001/jama.2019.11455.

    PubMed 31573636

  • Chabanne R, Geeraerts T, Begard M, Balanca B, Rapido F, Degos V, Tavernier B, Molliex S, Velly L, Verdonk F, Lukaszewicz AC, Perrigault PF, Albucher JF, Cognard C, Guyot A, Fernandez C, Masgrau A, Moreno R, Ferrier A, Jaber S, Bazin JE, Pereira B, Futier E; ANARLF NetworkAMETIS Study Group. Outcomes After Endovascular Therapy With Procedural Sedation vs General Anesthesia in Patients With Acute Ischemic Stroke: The AMETIS Randomized Clinical Trial. JAMA Neurol. 2023 May 1;80(5):474-483. doi: 10.1001/jamaneurol.2023.0413.

    PubMed 37010829

  • Maurice A, Eugene F, Ronziere T, Devys JM, Taylor G, Subileau A, Huet O, Gherbi H, Laffon M, Esvan M, Laviolle B, Beloeil H; GASS (General Anesthesia versus Sedation for Acute Stroke Treatment) Study Group and the French Society of Anesthesiologists (SFAR) Research Network. General Anesthesia versus Sedation, Both with Hemodynamic Control, during Intraarterial Treatment for Stroke: The GASS Randomized Trial. Anesthesiology. 2022 Apr 1;136(4):567-576. doi: 10.1097/ALN.0000000000004142.

    PubMed 35226737

  • Quintard H, Degos V, Mazighi M, Berge J, Boussemart P, Chabanne R, Figueiredo S, Geeraerts T, Launey Y, Meuret L, Olivot JM, Pottecher J, Rapido F, Richard S, Saleme S, Siguret-Depasse V, Naggara O, De Courson H, Garnier M. Anaesthetic and peri-operative management for thrombectomy procedures in stroke patients. Anaesth Crit Care Pain Med. 2023 Feb;42(1):101188. doi: 10.1016/j.accpm.2022.101188. Epub 2023 Jan 1.

    PubMed 36599377

  • Turc G, Bhogal P, Fischer U, Khatri P, Lobotesis K, Mazighi M, Schellinger PD, Toni D, de Vries J, White P, Fiehler J. European Stroke Organisation (ESO) - European Society for Minimally Invasive Neurological Therapy (ESMINT) Guidelines on Mechanical Thrombectomy in Acute Ischaemic StrokeEndorsed by Stroke Alliance for Europe (SAFE). Eur Stroke J. 2019 Mar;4(1):6-12. doi: 10.1177/2396987319832140. Epub 2019 Feb 26.

    PubMed 31165090

  • Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL; American Heart Association Stroke Council. 2018 Guidelines for the Early Management of Patients With Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2018 Mar;49(3):e46-e110. doi: 10.1161/STR.0000000000000158. Epub 2018 Jan 24.

    PubMed 29367334

Questions about this trial

What is this clinical trial studying?

A study testing General Anesthesia and Procedural sedation in people with Ischemic Stroke and Anterior Cerebral Circulation, run by University Hospital, Clermont-Ferrand at 16 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 9 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: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lise Laclautre (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

modified Rankin Scale (time frame: Day 90 after the stroke). 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 NCT07235514, which also lists 6 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 2 Sep 2026.

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