Clinical trial NCT03776877: Endovascular Treatment in Ischemic Stroke Follow-up Evaluation
Official title: Evaluation of Clinical and Imaging Criteria, and Plasma Biomarkers of Patients Receiving an Endovascular Treatment for an Acute Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke, Acute
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2018-12-17
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with stroke treated by thrombectomy.

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.


Eligibility criteria: Inclusion Criteria:

* 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:

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

Primary outcomes:
measure: Clinical outcome
timeFrame: Day 90
Secondary outcomes:
measure: Efficacy on reperfusion (modified Thrombolysis in Cerebral Infarction (mTICI) 2b/3)
timeFrame: Day 1
measure: Efficacy on revascularization (>= mTICI 2b)
timeFrame: Day 1
measure: Efficacy on clinical outcome (mRS=0-1)
timeFrame: Day 90
measure: Efficacy on functional independence (mRS 0-2)
timeFrame: Day 90
measure: Hemorrhage evaluated by imagery
timeFrame: Day 0
measure: Hematoma rate
timeFrame: Day 1
measure: Mortality rate
timeFrame: Day 90
measure: Complication rate
timeFrame: Day 0
measure: ASPECT (Alberta Stroke Program Early CT score)
timeFrame: Day O
measure: Parametric imaging
timeFrame: Day 0
measure: Imaging data
timeFrame: Day 1
measure: Blood sampling for research purpose
timeFrame: Day 0
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Caen
country: France
facility: CHU de Caen
city: Le Kremlin-Bicêtre
country: France
facility: Hôpital le Kremlin-Bicètre - APHP
city: Limoges
country: France
facility: CHU Dupuytren
city: Lyon
country: France
facility: CHU Lyon
city: Montpellier
country: France
facility: CHU Montpellier
city: Nancy
country: France
facility: CHU Nancy
city: Nantes
country: France
facility: CHU Nantes
city: Paris
country: France
facility: Hôpital Pitié Salpétrière
city: Paris
country: France
facility: Hôpital SAINTE ANNE
city: Paris
country: France
facility: Fondation Ophtalmique de Rotschild
city: Rennes
country: France
facility: CHU Rennes
city: Rouen
country: France
facility: Chu Rouen
city: Suresnes
country: France
facility: Hôpital Foch
city: Toulouse
country: France
facility: CHU Toulouse
city: Vannes
country: France
facility: CH Bretagne Atlantique
Study officials:
affiliation: Hopital Foch
name: Bertrand Larpergue, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.