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

Cerebrovascular Accident Clinical Trial

— THRACE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01062698
• Other study ID #: 2009-A00753-54
• Status: Terminated
• Phase: N/A
• First received: February 3, 2010
• Last updated: July 20, 2017
• Start date: June 2010
• Est. completion date: March 2016

Study information

• Verified date: July 2017
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 412
• Est. completion date: March 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Stroke
• Cerebrovascular Accident
• Stroke

Intervention

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

Locations

Country	Name	City	State
France	Central Hospital Nancy (Central HNF)	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Rankin Score (mRs )		3 months after treatment
Secondary	Quality of Life (Euroqol EQ-5D)		3 months after treatment
Secondary	Barthel Score		3 months after treatment