NCT03776877

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Longer than P75 for all trials

Geographic Reach
1 country

16 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 26, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 17, 2018

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

August 3, 2022

Status Verified

August 1, 2022

Enrollment Period

4.4 years

First QC Date

September 10, 2018

Last Update Submit

August 2, 2022

Conditions

Stroke, Acute

Outcome Measures

Primary Outcomes (1)

  • Clinical outcome

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

    Day 90

Secondary Outcomes (12)

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

    Day 1

  • Efficacy on revascularization (>= mTICI 2b)

    Day 1

  • Efficacy on clinical outcome (mRS=0-1)

    Day 90

  • Efficacy on functional independence (mRS 0-2)

    Day 90

  • Hemorrhage evaluated by imagery

    Day 0

  • +7 more secondary outcomes

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with stroke treated by thrombectomy.

You may qualify if:

  • 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)
  • Pregnant or breast-feeding women
  • Patient benefiting from a legal protection
  • Non-membership of a national insurance scheme

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

CHU Bordeaux

Bordeaux, France

RECRUITING

CHU de Caen

Caen, France

RECRUITING

Hôpital le Kremlin-Bicètre - APHP

Le Kremlin-Bicêtre, France

RECRUITING

CHU Dupuytren

Limoges, 87042, France

RECRUITING

CHU Lyon

Lyon, France

NOT YET RECRUITING

CHU Montpellier

Montpellier, France

RECRUITING

CHU Nancy

Nancy, France

RECRUITING

CHU Nantes

Nantes, France

RECRUITING

Hôpital Pitié Salpétrière

Paris, 75013, France

RECRUITING

Hôpital SAINTE ANNE

Paris, 75014, France

RECRUITING

Fondation Ophtalmique de Rotschild

Paris, France

RECRUITING

CHU Rennes

Rennes, France

RECRUITING

Chu Rouen

Rouen, 76100, France

RECRUITING

Hôpital Foch

Suresnes, 92150, France

RECRUITING

CHU Toulouse

Toulouse, 31300, France

RECRUITING

CH Bretagne Atlantique

Vannes, 56017, France

ACTIVE NOT RECRUITING

Related Publications (10)

  • 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. 2025 May 2:jnis-2025-023260. doi: 10.1136/jnis-2025-023260. Online ahead of print.

    PMID: 40316319DERIVED

  • 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.

    PMID: 39397363DERIVED

  • 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.

    PMID: 37847131DERIVED

  • 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.

    PMID: 37442271DERIVED

  • 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.

    PMID: 37288701DERIVED

  • 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.

    PMID: 34727741DERIVED

  • 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.

    PMID: 34706564DERIVED

  • 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.

    PMID: 34433309DERIVED

  • 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.

    PMID: 32606101DERIVED

  • 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.

    PMID: 31670928DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Bertrand Larpergue, MD

    Hopital Foch

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisabeth Hulier-Ammar

CONTACT

+33146251175drci-promotion@hopital-foch.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
90 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2018

First Posted

December 17, 2018

Study Start

June 26, 2018

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

August 3, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(16)