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Endovascular Treatment in Ischemic Stroke Follow-up Evaluation

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03776877
Acronym
ETIS
Enrollment
4000
Registered
2018-12-17
Start date
2018-06-26
Completion date
2022-12-31
Last updated
2022-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke, Acute

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.

Interventions

None listed

Sponsors

Hopital Foch
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Clinical outcomeDay 90modified Rankin score (mRS), score 0 to 6 with 0 = no symptoms and 6 = death.

Secondary

MeasureTime frameDescription
Efficacy on revascularization (>= mTICI 2b)Day 1Time to achieve TICI 2b or better revascularization
Efficacy on clinical outcome (mRS=0-1)Day 90Rate of excellent functional outcome defined as a modified Rankin score (mRS) 0-1
Efficacy on functional independence (mRS 0-2)Day 90Rate of functional independence defined as a modified Rankin score 0-2
Hemorrhage evaluated by imageryDay 0Rate of symptomatic and asymptomatic intracerebral hemorrhage at MRI or CT scan
Hematoma rateDay 1Rate of parenchymal hematoma 2
Efficacy on reperfusion (modified Thrombolysis in Cerebral Infarction (mTICI) 2b/3)Day 1Rate of complete or near complete reperfusion (modified Thrombolysis in Cerebral Infarction (mTICI) 2b/3)
Complication rateDay 0Rate of periprocedural complications
ASPECT (Alberta Stroke Program Early CT score)Day OMeasure by Axial imaging, 10-point quantitative topographic CT scan score
Parametric imagingDay 0Diffusion, volume clinical-diffusion mismatch
Imaging dataDay 1Angiographic imaging
Blood sampling for research purposeDay 0Search of biomarkers of stroke etiology and recovery
Mortality rateDay 90Rate of all-cause mortality

Countries

France

Contacts

Primary ContactElisabeth Hulier-Ammar
drci-promotion@hopital-foch.com+33146251175

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 18, 2026