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

Central Hospital, Nancy, France

Status

Terminated

Conditions

Cerebrovascular Accident

Cerebral Stroke

Treatments

Drug: Alteplase (rt-PA)/Actilyse

Procedure: Mechanic thrombectomy (MERCI, PENUMBRA, CATCH, SOLITAIRE)

Study type

Interventional

Funder types

Other

Identifiers

NCT01062698

2009-A00753-54

Details and patient eligibility

About

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.

Enrollment

412 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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