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

Terminated

Phase N/A Results N/A

Trial Description

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.

Trial Stopped: Efficacy

Conditions

Interventions

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Investigator)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

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

Sponsors