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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

412 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2016-03-31

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.

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Detailed Description

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Conditions

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Cerebral Stroke Cerebrovascular Accident

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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IV thrombolysis + thrombectomy

Group Type ACTIVE_COMPARATOR

Alteplase (rt-PA)/Actilyse

Intervention Type DRUG

Injection of 0.9 mg/kg for 60min with an initial 10% bolus injection.

Mechanic thrombectomy (MERCI, PENUMBRA, CATCH, SOLITAIRE)

Intervention Type PROCEDURE

Mechanic thrombectomy

IV thrombolysis

Group Type ACTIVE_COMPARATOR

Alteplase (rt-PA)/Actilyse

Intervention Type DRUG

Injection of 0.9 mg/kg for 60min with an initial 10% bolus injection.

Interventions

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Alteplase (rt-PA)/Actilyse

Injection of 0.9 mg/kg for 60min with an initial 10% bolus injection.

Intervention Type DRUG

Mechanic thrombectomy (MERCI, PENUMBRA, CATCH, SOLITAIRE)

Mechanic thrombectomy

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No