COmparing CeNters ThRombectomy Aspiration STentretriever

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-01

Study Completion Date

2021-06-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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A Direct Aspiration First Pass Technique

Intervention Type OTHER

Distal aspiration technique

Stentriever Thrombectomy

Intervention Type OTHER

Thrombectomy with stent retriever

Interventions

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A Direct Aspiration First Pass Technique

Distal aspiration technique

Intervention Type OTHER

Stentriever Thrombectomy

Thrombectomy with stent retriever

Intervention Type OTHER

Eligibility Criteria

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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 2-30.
* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Alejandro González

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alejandro González, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospitales Universitarios Virgen del Rocío

Locations

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