Clinical trial NCT03412851: COmparing CeNters ThRombectomy Aspiration STentretriever
Official title: COmparing CeNters ThRombectomy Aspiration STentretriever
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Stroke
Keywords: Thrombectomy
Stentriever
ADAPT
Lead sponsor: Hospitales Universitarios Virgen del Rocío
Sponsor class: OTHER
First posted: 2018-01-29
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with 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).

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.


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 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.

Primary outcomes:
measure: modified rankin scale (mRs) at 90 days [effectiveness]
timeFrame: 90 days
Secondary outcomes:
measure: Symptomatic intracranial bleeding [safety of the technique]
timeFrame: First 14 days
measure: Thrombolysis in cerebral infarction (TICI) scale 2b-3 [effectiveness]
timeFrame: Up to 24 hours after endovascular reperfusion
Other outcomes:
Locations:
city: Bilbao
country: Spain
facility: Hospital Universitario de Cruces
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Las Palmas De Gran Canaria
country: Spain
facility: Hospital Universitario Insular de Gran Canaria
city: Murcia
country: Spain
facility: Hospital Clínico Universitario Virgen de la Arrixaca
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: San Sebastián
country: Spain
facility: Hospital Universitario de Donostia
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario
Study officials:
affiliation: Hospitales Universitarios Virgen del Rocío
name: Alejandro González, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: