Ischemic stroke
Conditions
Brief summary
The primary endpoint is the severity of disability according to the shift of scores on the modified Rankin Scale (mRS) at 90 (±15) days.
Detailed description
1a) EFFICACY: -Distribution of the mRS score at day 90 (±15)., 1a) EFFICACY: -Excellent functional outcome (mRS 0-1) at 90 (±15) day., 1a) EFFICACY: -Functional independence (mRS 0-2) at 90 (±15) day., 1a) EFFICACY: -Early neurological improvement (reduction in National Institutes of Health Stroke Scale (NIHSS) score by at least 8 points, or NIHSS score of 0-1) at 24 (±6) hours., 1a) EFFICACY: -eTICI at the end of endovascular procedure (including IA thrombolysis in the intervention group)., 1a) EFFICACY: -Infarct growth: difference in (i) ASPECTS scores and (ii) infarct core volume (MRI DWI or CT perfusion) between 24 (±6) hours and baseline, 1b) SAFETY: -Complications during endovascular treatment: arterial perforation, extracranial carotid dissection, embolization in a new territory., 1b) SAFETY: -Symptomatic and asymptomatic intracerebral hemorrhage within 24-hour on CT or MRI, according to the Heidelberg classification (imaging core laboratory)., 1b) SAFETY: -Extracranial hemorrhage requiring transfusion, surgery or resulting in death, 1b) SAFETY: -Death from all causes within 90 (±15) days, 2) COST EFFECTIVENESS: Incremental cost-effectiveness and cost-utility ratios of a strategy based on adjunct IA thrombolysis in case of successful angiographic reperfusion compared with a strategy of no adjunct IA thrombolysis., 3) TOTAL COST: Total cost of each treatment strategy and net impact on the National Health Insurance System (difference in costs).
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the severity of disability according to the shift of scores on the modified Rankin Scale (mRS) at 90 (±15) days. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1a) EFFICACY: -Distribution of the mRS score at day 90 (±15)., 1a) EFFICACY: -Excellent functional outcome (mRS 0-1) at 90 (±15) day., 1a) EFFICACY: -Functional independence (mRS 0-2) at 90 (±15) day., 1a) EFFICACY: -Early neurological improvement (reduction in National Institutes of Health Stroke Scale (NIHSS) score by at least 8 points, or NIHSS score of 0-1) at 24 (±6) hours., 1a) EFFICACY: -eTICI at the end of endovascular procedure (including IA thrombolysis in the intervention group)., 1a) EFFICACY: -Infarct growth: difference in (i) ASPECTS scores and (ii) infarct core volume (MRI DWI or CT perfusion) between 24 (±6) hours and baseline, 1b) SAFETY: -Complications during endovascular treatment: arterial perforation, extracranial carotid dissection, embolization in a new territory., 1b) SAFETY: -Symptomatic and asymptomatic intracerebral hemorrhage within 24-hour on CT or MRI, according to the Heidelberg classification (imaging core laboratory)., 1b) SAFETY: -Extracranial hemorrha | — |
Countries
France