Clinical trial NCT03407092: Thrombectomy In ANdalucia Using Aspiration (TRIANA)
Official title: Thrombectomy In ANdalucia Using Aspiration (TRIANA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke, Acute
Lead sponsor: Hospitales Universitarios Virgen del Rocío
Sponsor class: OTHER
Collaborators: name: Andaluz Health Service
First posted: 2018-01-23
Enrollment: 532
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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:

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.

1. To evaluate the safety and effectiveness of thrombectomy with manual mechanical aspiration with Sofia Plus under clinical practice conditions.
2. Determine if the duration (puncture-recanalization) of thrombectomy with aspiration is less than that of stents retrievers; And if the number of embolisms distal to new vascular territories decreases with aspiration.
3. To estimate the cost savings by procedure in the treatment of ischemic stroke and to analyze the efficiency (cost effectiveness) of thrombectomy with aspiration.

Eligibility criteria: 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 2-30.
* 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.

Primary outcomes:
measure: modified rankin scale (mRs) at 90 days
timeFrame: 90 days
Secondary outcomes:
measure: Symptomatic Intracranial bleeding
timeFrame: during admission
measure: Haemorrhagic tranformation
timeFrame: during admission
measure: Thrombolysis in cerebral infarction (TICI) scale
timeFrame: Up to 24 hours after endovascular reperfusion
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
Study officials:
affiliation: Hospitales Universitarios Virgen del Rocío
name: Alejandro González, Md, PhD
role: PRINCIPAL_INVESTIGATOR
References: