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

• Quality of Life (Euroqol EQ-5D) [ Time Frame: 3 months after treatment ] [ Designated as safety issue: Yes ]
• Barthel Score [ Time Frame: 3 months after treatment ] [ Designated as safety issue: Yes ]

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.

• Cerebral Stroke
• Cerebrovascular Accident

• 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

• Active Comparator: IV thrombolysis + thrombectomy
  Interventions:

  • Drug: Alteplase (rt-PA)/Actilyse
  • Procedure: Mechanic thrombectomy (MERCI, PENUMBRA, CATCH, SOLITAIRE)
• Active Comparator: IV thrombolysis
  Intervention: Drug: Alteplase (rt-PA)/Actilyse

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