COmparing CeNters ThRombectomy Aspiration STentretriever (CONTRAST)

Hospitales Universitarios Virgen del Rocío

Status

Unknown

Conditions

Acute Stroke

Treatments

Other: A Direct Aspiration First Pass Technique

Other: Stentriever Thrombectomy

Study type

Observational

Funder types

Other

Identifiers

NCT03412851

CO-18-V1.0

Details and patient eligibility

About

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.

Enrollment

1,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.