Endovascular Treatment in Ischemic Stroke Follow-up Evaluation

• Conditions: Stroke, Acute

• Registration Number: NCT03776877
• Lead Sponsor: Hopital Foch

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-26
• Study First Submitted: 2018-09-10
• Study First Submitted QC: 2018-12-13
• Study First Posted: 2018-12-17
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-03
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 4000

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical outcome	Day 90	modified Rankin score (mRS), score 0 to 6 with 0 = no symptoms and 6 = death.

Secondary Outcome Measures

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

Trial Locations

Locations (16)

CHU Bordeaux; 🇫🇷 Bordeaux, France

CHU de Caen; 🇫🇷 Caen, France

Hôpital le Kremlin-Bicètre - APHP; 🇫🇷 Le Kremlin-Bicêtre, France

CHU Montpellier; 🇫🇷 Montpellier, France

CHU Lyon; 🇫🇷 Lyon, France

CHU Dupuytren; 🇫🇷 Limoges, France

CHU Nancy; 🇫🇷 Nancy, France

CHU Nantes; 🇫🇷 Nantes, France

Hôpital Pitié Salpétrière; 🇫🇷 Paris, France

Hôpital SAINTE ANNE; 🇫🇷 Paris, France

Fondation Ophtalmique de Rotschild; 🇫🇷 Paris, France

Chu Rouen; 🇫🇷 Rouen, France

CHU Toulouse; 🇫🇷 Toulouse, France

Hôpital Foch; 🇫🇷 Suresnes, France

CH Bretagne Atlantique; 🇫🇷 Vannes, France

CHU Rennes; 🇫🇷 Rennes, France