Endovascular Treatment in Ischemic Stroke Follow-up Evaluation

Stroke, Acute Clinical Trial

— ETIS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03776877
• Other study ID #: 2017024F
• Status: Recruiting
• Start date: June 26, 2018
• Est. completion date: December 2022

Study information

• Verified date: August 2022
• Source: Hopital Foch
• Contact: Elisabeth Hulier-Ammar
• Phone: +33146251175
• Email: drci-promotion[@]hopital-foch.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke
• Stroke, Acute

Locations

Country	Name	City	State
France	CHU Bordeaux	Bordeaux
France	CHU de Caen	Caen
France	Hôpital le Kremlin-Bicètre - APHP	Le Kremlin-Bicêtre
France	CHU Dupuytren	Limoges
France	CHU Lyon	Lyon
France	CHU Montpellier	Montpellier
France	CHU Nancy	Nancy
France	CHU Nantes	Nantes
France	Fondation Ophtalmique de Rotschild	Paris
France	Hôpital Pitié Salpétrière	Paris
France	Hôpital SAINTE ANNE	Paris
France	CHU Rennes	Rennes
France	Chu Rouen	Rouen
France	Hôpital Foch	Suresnes
France	CHU Toulouse	Toulouse
France	CH Bretagne Atlantique	Vannes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical outcome	modified Rankin score (mRS), score 0 to 6 with 0 = no symptoms and 6 = death.	Day 90
Secondary	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)	Day 1
Secondary	Efficacy on revascularization (>= mTICI 2b)	Time to achieve TICI 2b or better revascularization	Day 1
Secondary	Efficacy on clinical outcome (mRS=0-1)	Rate of excellent functional outcome defined as a modified Rankin score (mRS) 0-1	Day 90
Secondary	Efficacy on functional independence (mRS 0-2)	Rate of functional independence defined as a modified Rankin score 0-2	Day 90
Secondary	Hemorrhage evaluated by imagery	Rate of symptomatic and asymptomatic intracerebral hemorrhage at MRI or CT scan	Day 0
Secondary	Hematoma rate	Rate of parenchymal hematoma 2	Day 1
Secondary	Mortality rate	Rate of all-cause mortality	Day 90
Secondary	Complication rate	Rate of periprocedural complications	Day 0
Secondary	ASPECT (Alberta Stroke Program Early CT score)	Measure by Axial imaging, 10-point quantitative topographic CT scan score	Day O
Secondary	Parametric imaging	Diffusion, volume clinical-diffusion mismatch	Day 0
Secondary	Imaging data	Angiographic imaging	Day 1
Secondary	Blood sampling for research purpose	Search of biomarkers of stroke etiology and recovery	Day 0