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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02216565 |
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Date of registration:
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13/08/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Embolectomy in Acute SYlvian Thrombosis in Refractory or Ineligible Patients to ALteplase
EASY |
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Scientific title:
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Benefits of the Endovascular Treatment in the Early Management of Proximal Sylvian Artery Thrombosis in Patients Refractory or Ineligible to Intravenous Fibrinolysis : a Multicenter Controled Randomized Trial |
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Date of first enrolment:
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December 1, 2014 |
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Target sample size:
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2 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02216565 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Michel Piotin, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Fondation Ophtalmologique Adolphe de Rothschild, Paris |
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Name:
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Marc-Antoine Labeyrie, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hopital Lariboisiere, Paris |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Radiologically proven acute proximal occlusion of middle cerebral artery
AND one of the three following :
1. tandem internal carotid / middle cerebral artery occlusion
2. intravenous thrombolysis contraindicated because of high risk of haemorrhage
3. intravenous thrombolysis not possible because of delay > 4.5 hours
Exclusion Criteria:
- Impossibility to perform endovascular recanalization within 6h
- Clinically minor stroke (NIHSS score below 5 at baseline)
- Extended cerebral infarction
- Severe comorbidity
- Life expectancy below 3 months before stroke
- Pregnancy or breastfeeding
- modified Rankin Score superior to 2 before stroke
Age minimum:
18 Years
Age maximum:
82 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Stroke, Acute
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Intervention(s)
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Other: Supportive care
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Other: Hospitalization in specialized neuro-vascular unit
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Procedure: Endovascular treatment
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Drug: Alteplase if patient is eligible
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Primary Outcome(s)
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Improvement in NIHSS score after 24h
[Time Frame: 24 hours]
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Secondary Outcome(s)
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Fatality within 3 months
[Time Frame: 3 months]
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Fatality within 7 days
[Time Frame: 7 days]
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Improvement in NIHSS score after 7 days
[Time Frame: 7 days]
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Functional recovery after 3 months
[Time Frame: 3 months]
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Secondary ID(s)
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2014-A00519-38
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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