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

NCT01062698 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 412

Last updated 2017-07-21

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Central Hospital, Nancy, France

    lead OTHER

Principal Investigators

  • Serge Bracard, Pr · Central Hospital Nancy France (HNF)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2015-12-31
Completion
2016-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01062698 on ClinicalTrials.gov