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

Terminated

Phase N/A Results N/A

Update History

22 Jul '17
The Summary of Purpose was updated.
New
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.
Old
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.
The gender criteria for eligibility was updated to "All."
2 Sep '15
A location was updated in Nancy.
New
The overall status was removed for Central Hospital Nancy (Central HNF).
22 Mar '12
The eligibility criteria were updated.
New
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
Old
Inclusion Criteria: - 10<=NIHSS Score=<25 - Symptoms onset less than 3 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
A location was updated in Nancy.
New
The overall status was removed for Central Hospital Nancy (Central HNF).
6 Oct '11
The Summary of Purpose was updated.
New
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.
Old
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.