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Stroke, AcuteETISNCT03776877

Endovascular Treatment in Ischemic Stroke Follow-up Evaluation

An observational study of Stroke, Acute, run by Hopital Foch at 16 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Study like register with biomarkers samples for patient experiencing acute ischemic stroke, to assess clinical outcomes and different factors that may affect the clinical outcomes. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Acute
How many people
4,000 participants
Where
16 sitesFrance
Study dates
26 Jun 2018to Dec 2022
How long will I take part?
90 Days
Phase
Observational
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

Study population: All patients with stroke treated by thrombectomy.

Who may be able to join

  • Age 18 and older (i.e., candidates must have had their 18th birthday)
  • Neuroimaging demonstrates acute ischemic stroke with large vessel proximal with the use of neuro-thrombectomy devices intended to restore blood flow
  • No upper or lower limits of the neurological severity at baseline (NIHSS).
  • With or without intravenous thrombolysis
  • Oral informed consent (patient and/or trustworthy person)
  • Non-inclusion Criteria:
Show all 9Show fewer
  • Pregnant or breast-feeding women
  • Patient benefiting from a legal protection
  • Non-membership of a national insurance scheme

Who cannot join

None listed.

Trial locations and contacts

16 sites in 1 country.

Elisabeth Hulier-Ammar contact

+33146251175

drci-promotion@hopital-foch.com

16 sites in 1 country

France16 sites, 15 recruiting

  • CHU Bordeaux

    Bordeaux

    Gaultier Marnat, MD, gaultier.marnat@chu-bordeaux.fr

    Gaultier Marnat, MD

    Recruiting

  • CHU de Caen

    Caen

    Emmanuel TOUZE, PhD, touze-e@chu-caen.fr

    Emmanuel TOUZE, MD

    Recruiting

  • Hôpital le Kremlin-Bicètre - APHP

    Le Kremlin-Bicêtre

    Laurent Spelle, MD, laurent.spelle@aphp.fr

    Laurent Spelle, MD

    Recruiting

  • CHU Dupuytren

    Limoges, 87042

    Charbel MOUNAYER, MD, charbel.mounayer@unilim.fr

    Charbel MOUNAYER, MD

    Recruiting

  • CHU Lyon

    Lyon

    Omer Eker, MD, Omer.eker@chu-lyon.fr

    Omer Eker, MD

    Not yet recruiting

  • CHU Montpellier

    Montpellier

    Cyril Dargazanli, MD, cyril.dargazanli@gmail.com

    Cyril Darganzanli, MD

    Recruiting

  • CHU Nancy

    Nancy

    Benjamin Gory, MD, b.gory@chu-nancy.fr

    Benjamin Gory, MD

    Recruiting

  • CHU Nantes

    Nantes

    Romain Bourcier, MD, Romain.bourcier@chu-nantes.fr

    Romain Bourcier, MD

    Recruiting

  • Hôpital Pitié Salpétrière

    Paris, 75013

    Frédéric CLARENCON, MD, frederic.clarencon@aphp.fr

    Frédéric CLARENCON, MD

    Recruiting

  • Hôpital SAINTE ANNE

    Paris, 75014

    Olivier NAGARRA, MD, O.NAGGARA@ch-sainte-anne.fr

    Olivier NAGARRA, MD

    Recruiting

  • Fondation Ophtalmique de Rotschild

    Paris

    Raphael Blanc, MD, rblanc@fo-rothschild.fr

    Raphael Blanc, MD

    Recruiting

  • CHU Rennes

    Rennes

    Jean-Christophe Ferre, MD, Jean-christophe.FERRE@chu-rennes.fr

    JC Ferre, MD

    Recruiting

  • Chu Rouen

    Rouen, 76100

    Olzem OZKUL-WERMESTER, MD, Ozlem.OzkulWermester@chu-rouen.fr

    Olzem OZKUL-WERMESTER, MD

    Recruiting

  • Hôpital Foch

    Suresnes, 92150

    Bertrand Lapergue, MD, +33(0)1 46 25 73 43, b.lapergue@hopital-foch.org

    Bertrand Lapergue, MD

    Recruiting

  • CHU Toulouse

    Toulouse, 31300

    Alain VIGUIER, MD, viguier.a@chu-toulouse.fr

    Alain VIGUIER, MD

    Recruiting

  • CH Bretagne Atlantique

    Vannes, 56017

    Active, not recruiting

Other trials in France

About this study

Official title: Evaluation of Clinical and Imaging Criteria, and Plasma Biomarkers of Patients Receiving an Endovascular Treatment for an Acute Ischemic Stroke

Study like register with biomarkers samples for patient experiencing acute ischemic stroke, to assess clinical outcomes and different factors that may affect the clinical outcomes.

Conditions
Stroke, Acute
Medical subject headings
Stroke

What participants receive

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

Study groups in NCT03776877
Study groupRoleWhat they receive
Arterial Ischemic Stroke (AIS)All patients (prospective and retrospective) included will have to present an Arterial Ischemic Stroke (AIS) from a large cerebral vessel occlusion. The participation in the study will consist in: * Plasmatic collection at the time of AIS, for study of plasma biomarkers * Additional standardized blinded clinical evaluation at three months after the thrombectomy realized during a phone call, particularly via an assessment of the modified Rankin score.

What is being measured

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

  1. Clinical outcome

    modified Rankin score (mRS), score 0 to 6 with 0 = no symptoms and 6 = death.

    Measured: Day 90

Secondary outcomes (12)

  1. Efficacy on reperfusion (modified Thrombolysis in Cerebral Infarction (mTICI) 2b/3)

    Rate of complete or near complete reperfusion (modified Thrombolysis in Cerebral Infarction (mTICI) 2b/3)

    Measured: Day 1

  2. Efficacy on revascularization (>= mTICI 2b)

    Time to achieve TICI 2b or better revascularization

    Measured: Day 1

  3. Efficacy on clinical outcome (mRS=0-1)

    Rate of excellent functional outcome defined as a modified Rankin score (mRS) 0-1

    Measured: Day 90

  4. Efficacy on functional independence (mRS 0-2)

    Rate of functional independence defined as a modified Rankin score 0-2

    Measured: Day 90

  5. Hemorrhage evaluated by imagery

    Rate of symptomatic and asymptomatic intracerebral hemorrhage at MRI or CT scan

    Measured: Day 0

  6. Hematoma rate

    Rate of parenchymal hematoma 2

    Measured: Day 1

  7. Mortality rate

    Rate of all-cause mortality

    Measured: Day 90

  8. Complication rate

    Rate of periprocedural complications

    Measured: Day 0

  9. ASPECT (Alberta Stroke Program Early CT score)

    Measure by Axial imaging, 10-point quantitative topographic CT scan score

    Measured: Day O

  10. Parametric imaging

    Diffusion, volume clinical-diffusion mismatch

    Measured: Day 0

  11. Imaging data

    Angiographic imaging

    Measured: Day 1

  12. Blood sampling for research purpose

    Search of biomarkers of stroke etiology and recovery

    Measured: Day 0

Timeline

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

  1. First posted17 Dec 2018
  2. Study start26 Jun 2018
  3. Primary completionDec 2022 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
4,000 participants (estimated)
Target duration
90 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT03776877
Sponsor's protocol ID
2017024F
Acronym
ETIS
Status last verified
Aug 2022
First submitted
10 Sep 2018
Last updated
3 Aug 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Authamayou B, Marnat G, Matsulevits A, Munsch F, Lavielle A, Corbin N, Foulon C, Chen B, Micard E, Gory B, L'Allinec V, Bourcier R, Naggara O, Lauze E, Boulouis G, Lapergue B, Eker O, Sibon I, Thiebaut de Schotten M, Tourdias T; ETIS Investigators. High-Resolution Disconnectome Predicts Outcome and Response to Thrombectomy in Basilar Artery Occlusion. Stroke. 2026 Sep 11. doi: 10.1161/STROKEAHA.126.056382. Online ahead of print.

    PubMed 42723634

  • Bousfiha C, Vinacci G, Gratieux J, Hmida I, Chadenat ML, Lapergue B, Wang A, Consoli A, Pico F. Clinical Significance of the Hyperintense Reperfusion Marker and Ocular Gadolinium Leakage After Thrombectomy: A Retrospective ETIS Study. Neurology. 2026 Sep 8;107(5):e218412. doi: 10.1212/WNL.0000000000218412. Epub 2026 Aug 11.

    PubMed 42579823

  • Milnerowicz M, Desilles JP, Pop R, Dargazanli C, Labreuche J, Sibon I, Gory B, Soize S, Bourcier R, Mazighi M, Cognard C, Caroff J, Gentric JC, Clarencon F, Richter S, Janot K, Lapergue B, Marnat G; ETIS investigators. Cangrelor versus GPIIb/IIIa inhibitors as adjunctive therapy in endovascular treatment of large vessel occlusion stroke. J Neurointerv Surg. 2026 Mar 13;18(4):904-913. doi: 10.1136/jnis-2025-023260.

    PubMed 40316319

  • Sadeler A, Finitsis S, Olivot JM, Richard S, Marnat G, Sibon I, Calviere L, Cognard C, Mazighi M, Desilles JP, Lapergue B, Tamazyan R, Zuber M, Gory B, Maier B. Impact of time from symptom onset to puncture, and puncture to reperfusion, in endovascular therapy in the late time window (>6 h). Int J Stroke. 2025 Mar;20(3):357-366. doi: 10.1177/17474930241300073. Epub 2024 Nov 21.

    PubMed 39501524

  • Dargazanli C, Mourand I, Mahmoudi M, Poirier L, Labreuche J, Weisenburger-Lile D, Gory B, Richard S, Ducroux C, Piotin M, Blanc R, Lucas L, Marnat G, Aubertin M, Arquizan C, Bourcier R, Detraz L, Vannier S, Guillen M, Eugene F, Walker G, Lun R, Dowlatshahi D, Shamy M, Consoli A, Costalat V, Lapergue B, Maier B, Guenego A, Fahed R. Endovascular treatment versus medical management for basilar artery occlusion with low-to-moderate symptoms (National Institutes of Health Stroke Scale < 10). Eur Stroke J. 2025 Jun;10(2):397-405. doi: 10.1177/23969873241290442. Epub 2024 Oct 13.

    PubMed 39397363

  • Derraz I, Moulin S, Gory B, Kyheng M, Arquizan C, Costalat V, Lapergue B; ETIS Investigators. Endovascular Thrombectomy Outcomes with and without Intravenous Thrombolysis for Large Ischemic Cores Identified with CT or MRI. Radiology. 2023 Oct;309(1):e230440. doi: 10.1148/radiol.230440.

    PubMed 37847131

  • Malka D, Janot K, Pasi M, Desilles JP, Marnat G, Sibon I, Consoli A, Dargazanli C, Arquizan C, Gory B, Richard S, Naggara O, Clarencon F, Rosso C, Bourcier R, Eker O, Caroff J, Lapergue B, Boulouis G; ETIS collaborators. Effects of weather conditions on endovascular treatment case volume for patients with ischemic stroke. J Neuroradiol. 2023 Nov;50(6):593-599. doi: 10.1016/j.neurad.2023.07.001. Epub 2023 Jul 11.

    PubMed 37442271

  • Bourcier R, Consoli A, Desilles JP, Labreuche J, Kyheng M, Desal H, Alias Q, Gory B, Dargazanli C, Janot K, Zhu F, Lapergue B, Marnat G. Temporal trends in results of endovascular treatment of anterior intracranial large cerebral vessel occlusion: A 7-year study. Eur Stroke J. 2023 Sep;8(3):655-666. doi: 10.1177/23969873231180338. Epub 2023 Jun 8.

    PubMed 37288701

  • Douarinou M, Gory B, Consoli A, Lapergue B, Kyheng M, Labreuche J, Anadani M, Blanc R, Marnat G, Bourcier R, Sibon I, Eugene F, Vannier S, Audibert G, Mione G, Richard S; ETIS Investigators. Impact of Strategy on Clinical Outcome in Large Vessel Occlusion Stroke Successfully Reperfused: ETIS Registry Results. Stroke. 2022 Jan;53(1):e1-e4. doi: 10.1161/STROKEAHA.121.034422. Epub 2021 Nov 3.

    PubMed 34727741

  • Happi Ngankou E, Gory B, Marnat G, Richard S, Bourcier R, Sibon I, Dargazanli C, Arquizan C, Maier B, Blanc R, Lapergue B, Consoli A, Vannier S, Spelle L, Denier C, Boulanger M, Gauberti M, Saleme S, Macian F, Clarencon F, Rosso C, Naggara O, Turc G, Ozkul-Wermester O, Papagiannaki C, Viguier A, Cognard C, Lebras A, Evain S, Wolff V, Pop R, Timsit S, Gentric JC, Bourdain F, Veunac L, Eugene F, Finitsis S; ETIS Registry Investigatorsdagger. Thrombectomy Complications in Large Vessel Occlusions: Incidence, Predictors, and Clinical Impact in the ETIS Registry. Stroke. 2021 Dec;52(12):e764-e768. doi: 10.1161/STROKEAHA.121.034865. Epub 2021 Oct 28.

    PubMed 34706564

  • Aubertin M, Weisenburger-Lile D, Gory B, Richard S, Blanc R, Ducroux C, Piotin M, Labreuche J, Lucas L, Dargazanli C, Benali A, Bourcier R, Detraz L, Vannier S, Guillen M, Eugene F, Walker G, Lun R, Guenego A, Consoli A, Marnat G, Maier B, Lapergue B, Fahed R; ETIS Investigators*. First-Pass Effect in Basilar Artery Occlusions: Insights From the Endovascular Treatment of Ischemic Stroke Registry. Stroke. 2021 Dec;52(12):3777-3785. doi: 10.1161/STROKEAHA.120.030237. Epub 2021 Aug 26.

    PubMed 34433309

  • Ducroux C, Renaud N, Bourcier R, Marnat G, Sibon I, Gory B, Richard S, Dargazanli C, Arquizan C, Eugene F, Vannier S, Labreuche J, Walker G, Blanc R, Obadia M, Consoli A, Lapergue B, Fahed R; ETIS investigators. Embolus Retriever with Interlinked Cages (ERIC) versus conventional stent retrievers for thrombectomy: a propensity score-based analysis. J Neurointerv Surg. 2021 Mar;13(3):255-260. doi: 10.1136/neurintsurg-2020-016289. Epub 2020 Jun 30.

    PubMed 32606101

  • Boisseau W, Fahed R, Lapergue B, Desilles JP, Zuber K, Khoury N, Garcia J, Maier B, Redjem H, Ciccio G, Smajda S, Escalard S, Taylor G, Mazighi M, Michel P, Gory B, Blanc R; ETIS Investigators. Predictors of Parenchymal Hematoma After Mechanical Thrombectomy: A Multicenter Study. Stroke. 2019 Sep;50(9):2364-2370. doi: 10.1161/STROKEAHA.118.024512. Epub 2019 Jul 22.

    PubMed 31670928

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke, Acute, run by Hopital Foch 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 9 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 3 Aug 2022. 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?

Results are not available in the source record.

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

Contact Elisabeth Hulier-Ammar (+33146251175, drci-promotion@hopital-foch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical outcome (time frame: Day 90). 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 NCT03776877, which also lists 13 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 3 Aug 2022; AzTrials last refreshed its copy on 6 Nov 2026.

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