NCT01062698

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 412 (actual)
• Sponsor: Central Hospital, Nancy, France · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Cerebral Stroke
• Cerebrovascular Accident

Interventions

Type	Name	Description
DRUG	Alteplase (rt-PA)/Actilyse	Injection of 0.9 mg/kg for 60min with an initial 10% bolus injection.
PROCEDURE	Mechanic thrombectomy (MERCI, PENUMBRA, CATCH, SOLITAIRE)	Mechanic thrombectomy

Timeline

• Start date: 2010-06-01
• Primary completion: 2015-12-01
• Completion: 2016-03-01
• First posted: 2010-02-04
• Last updated: 2017-07-21

Locations

1 site across 1 country: France