Thrombectomy In ANdalucia Using Aspiration (TRIANA)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 532
- Locations
- 1
- Primary Endpoint
- modified rankin scale (mRs) at 90 days
Study Overview
Brief Summary
This study aims to compare the efficacy and safety of ADAPT vs Stentriever techique in a multicenter stroke cohort of patients.
Detailed Description
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:
- 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.
-
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.
-
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject experiencing an acute ischemic stroke in which imaging demonstrates a vascular occlusion located in the distal internal carotid artery (ICA) through the distal middle cerebral artery (MCA).
- •Subjects in which the aspiration technique is used for at least the first two thrombectomy passes per occluded vessel.
- •Subjects older than 18 years old.
- •Subjects with a prestroke modified Rankin scale of 0-2 and presenting with an NIHSS of 2-
- •Subjects that the operator feels may be treated with endovascular therapy.
- •Subjects in which computed tomography (CT)/Magnetic Resonance Imaging (MRI) demonstrates an infarct size of less than 70cc on MRI or Alberta Stroke Program Early CT (ASPECTS) score overall of 6 or better.
- •Subjects in which groin puncture can be obtained within 6 hours of symptom onset (with or without Total Plasminogen Activator administration). In those Patients of more than 8 hours or awake stroke or of unknown onset should be individualized the treatment and must exist area of penumbra in CT perfusion.
- •Subjects who have consented in accordance with local Institutional Review Board requirements.
Exclusion Criteria
- •Absence of large vessel occlusion on neuroimaging.
- •Platelet count < 100 x 10³ cells/mm³ or known platelet dysfunction.
- •Contraindication to CT and/or MRI (i.e., due to contrast allergy or prior implant that precludes MRI imaging).
- •Previously documented contrast allergy that is not amenable to medical treatment.
- •Women who are pregnant or breastfeeding at time of intervention.
- •Evidence of brain hemorrhage on CT and/or MRI at presenting hospital.
Outcomes
Primary Outcomes
modified rankin scale (mRs) at 90 days
Time Frame: 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 1. No significant disability despite symptoms; able to carry out all usual duties and activities 2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. Moderate disability; requiring some help, but able to walk without assistance 4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. Dead
Secondary Outcomes
- Symptomatic Intracranial bleeding(during admission)
- Haemorrhagic tranformation(during admission)
- Thrombolysis in cerebral infarction (TICI) scale(Up to 24 hours after endovascular reperfusion)
Investigators
Alejandro González
Principal Investigator
Hospitales Universitarios Virgen del Rocío