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| Name | Class |
|---|---|
| Andaluz Health Service | OTHER_GOV |
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This study aims to compare the efficacy and safety of ADAPT vs Stentriever techique in a multicenter stroke cohort of patients.
In Andalusia, current data show that the mortality rate from stroke is 50% higher than in Spain as a whole. Endovascular therapy has revolutionized the treatment of acute stroke and could improve these high mortality rates. The investigators propose to take the great advance that the thrombectomy has given to the community of Andalusia in which there are more limited resources with several strategies such as the implementation of strict protocols of inclusion through a common registry, use of cheaper equipment (aspiration vs stent-retrievers)
The objective of the TRIANA trial is thus to:
1. Demonstrate that the use of thrombectomy systems with direct aspiration first pass technique (ADAPT ) using the new large-bore 6F SOFIA Plus catheter (MicroVention, Inc., a wholly owned subsidiary of Terumo Corporation) is equal in safety and efficacy to the results of thrombectomy with stent retriever.
2) The use of mechanical aspiration systems would lead to a decrease in cost per procedure, shortening the duration of treatment and decrease the rate of embolism to new territory.
3) Identify futile recanalization blood biomarkers that will allow the investigators in the future to treat only those patients who will benefit from the most adequate reperfusion treatment.
The design is an observational, prospective and multicentric study of patients with acute ischemic stroke of anterior circulation and less than 8 hours of evolution treated with neurointerventionist rescue techniques to study safety, effectiveness, costs of the intervention and duration (puncture-recanalization) of the thrombectomy system with aspiration with Sofia Plus in comparison with the stent retrievers system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stentriever Cohort |
| ||
| ADAPT cohort |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADAPT cohort | Other | Thrombectomy with distal aspiration technique |
| |
| Measure | Description | Time Frame |
|---|---|---|
| modified rankin scale (mRs) at 90 days | Is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Score Description: The scale runs from 0-6, running from perfect health without symptoms to death. 0 No symptoms at all
| 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Symptomatic Intracranial bleeding | during admission | |
| Haemorrhagic tranformation | Haemorrhagic tranformation in control computed tomography after thrombectomy. | during admission |
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Inclusion Criteria:
Exclusion Criteria:
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All consecutive patients with ischemic stroke in which imaging demonstrates a vascular occlusion located in the distal internal carotid artery (ICA) through the distal middle cerebral artery (MCA) who require endovascular reperfusion.
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| Name | Affiliation | Role |
|---|---|---|
| Alejandro González, Md, PhD | Hospitales Universitarios Virgen del Rocío | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Virgen del Rocío | Seville | 41013 | Spain |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Stentriever Cohort |
| Other |
Thrombectomy with stent retriever |
|
| Thrombolysis in cerebral infarction (TICI) scale | It´s a tool for determining the response of thrombolytic/thrombectomy therapy for ischaemic stroke. In neurointerventional radiology it is commonly used for patients post endovascular revascularisation. Like most therapy response grading systems, it predicts prognosis. Classification The description is based on the angiographic appearances of the treated occluded vessel and the distal branches: Grade 0: no perfusion Grade 1: penetration with minimal perfusion Grade 2: partial perfusion Grade 2A: only partial filling (less than two-thirds) of the entire vascular territory is visualized Grade 2B: complete filling of all of the expected vascular territory is visualized but the filling is slower than normal Grade 3: complete perfusion | Up to 24 hours after endovascular reperfusion |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |