Trial and Cost Effectiveness Evaluation of Intra-arterial Thrombectomy in Acute Ischemic Stroke

Study Overview
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Brief Summary
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THRACE is a controled, multicenter and randomized trial. The primary objective of this study is to determine whether a combined approach intravenous thrombolysis (IV) + Mechanical thrombectomy is superior to the reference treatment with IV thrombolysis alone, in the 3 hours of onset of symptoms in patients with occlusion of proximal cerebral arteries and with a neurological impairment accident (National Institutes of Health Stroke Scale [NIHSS] ≥ 10). The second objective is to determine the cost-effectiveness of this procedure compared to the standard (IV thrombolysis). The assumption is that the combined approach, by improving the clinical outcome and speed recovery, allows for lower overall costs to the IV thrombolysis in 3 months and less than or at worst neutral to 1 year.

Official Title
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The Contribution of Intra-arterial Thrombectomy in Acute Ischemic Stroke in Patients Treated With Intravenous Thrombolysis

Conditions
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Cerebral Stroke, Cerebrovascular Accident

Intervention / Treatment
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* Drug: Alteplase (rt-PA)/Actilyse
* Procedure: Mechanic thrombectomy (MERCI, PENUMBRA, CATCH, SOLITAIRE)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 10<=NIHSS Score=<25 Symptoms onset less than 4 hours Occlusion of the intracranial carotid, the middle cerebral artery (M1) or the upper third of the basilar Exclusion Criteria: Contraindications for intravenous thrombolysis Occlusion or stenosis of the pre-occlusive cervical internal carotid artery ipsilateral to the lesion Any cause local prohibiting femoral catheterization

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IV thrombolysis + thrombectomy<br> | Drug: Alteplase (rt-PA)/Actilyse<br>* Injection of 0.9 mg/kg for 60min with an initial 10% bolus injection.<br>Procedure: Mechanic thrombectomy (MERCI, PENUMBRA, CATCH, SOLITAIRE)<br>* Mechanic thrombectomy<br>|
| Active Comparator: IV thrombolysis<br> | Drug: Alteplase (rt-PA)/Actilyse<br>* Injection of 0.9 mg/kg for 60min with an initial 10% bolus injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Rankin Score (mRs ) |  | 3 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life (Euroqol EQ-5D) |  | 3 months after treatment | 
| Barthel Score |  | 3 months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mechanical Thrombectomy, CVA (Cerebrovascular Accident), Cerebrovascular Accident, Acute