Status:
UNKNOWN
COmparing CeNters ThRombectomy Aspiration STentretriever
Lead Sponsor:
Hospitales Universitarios Virgen del Rocío
Conditions:
Acute Stroke
Eligibility:
All Genders
18+ years
Brief Summary
Our aims is to evaluate the equality in efficacy and safety between direct aspiration technique and stent retriever thrombectomy procedure in anterior circulation strokes in a multicenter, prospective...
Eligibility Criteria
Inclusion
- 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 yo.
- 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
- 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.
Key Trial Info
Start Date :
April 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2021
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT03412851
Start Date
April 1 2018
End Date
June 1 2021
Last Update
February 18 2020
Active Locations (9)
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1
Hospital Universitario de Cruces
Bilbao, Spain
2
Hospital Universitario Reina Sofia
Córdoba, Spain
3
Hospital Universitario Virgen de las Nieves
Granada, Spain
4
Hospital Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria, Spain