COmparing CeNters ThRombectomy Aspiration STentretriever
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 1,000
- Locations
- 9
- Primary Endpoint
- modified rankin scale (mRs) at 90 days [effectiveness]
Study Overview
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 study.
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 yo.
- •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 [effectiveness]
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 No significant disability despite symptoms; able to carry out all usual duties and activities Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance Moderate disability; requiring some help, but able to walk without assistance Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance Severe disability; bedridden, incontinent and requiring constant nursing care and attention Dead \[Time Frame: 90 days\]
Secondary Outcomes
- Symptomatic intracranial bleeding [safety of the technique](First 14 days)
- Thrombolysis in cerebral infarction (TICI) scale 2b-3 [effectiveness](Up to 24 hours after endovascular reperfusion)
Investigators
Alejandro González
Principal Investigator
Hospitales Universitarios Virgen del Rocío