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

Not Applicable

Terminated

• Conditions: Cerebral Stroke; Cerebrovascular Accident
• Interventions: Drug: Alteplase (rt-PA)/Actilyse; Procedure: Mechanic thrombectomy (MERCI, PENUMBRA, CATCH, SOLITAIRE)

• Registration Number: NCT01062698
• Lead Sponsor: Central Hospital, Nancy, France

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-02-03
• Study First Submitted QC: 2010-02-03
• Study First Posted: 2010-02-04
• Study Start: 2010-06
• Primary Completion: 2015-12
• Study Completion: 2016-03
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-20
• Last Update Posted: 2017-07-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 412

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IV thrombolysis + thrombectomy	Alteplase (rt-PA)/Actilyse	-
IV thrombolysis + thrombectomy	Mechanic thrombectomy (MERCI, PENUMBRA, CATCH, SOLITAIRE)	-
IV thrombolysis	Alteplase (rt-PA)/Actilyse	-

Primary Outcome Measures

Name	Time	Method
Modified Rankin Score (mRs )	3 months after treatment

Secondary Outcome Measures

Name	Time	Method
Quality of Life (Euroqol EQ-5D)	3 months after treatment
Barthel Score	3 months after treatment

Trial Locations

Locations (1)

Central Hospital Nancy (Central HNF); 🇫🇷 Nancy, France