COmparing CeNters ThRombectomy Aspiration STentretriever

• Conditions: Acute Stroke
• Interventions: Other: Stentriever Thrombectomy; Other: A Direct Aspiration First Pass Technique

• Registration Number: NCT03412851
• Lead Sponsor: Hospitales Universitarios Virgen del Rocío

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-12
• Study First Submitted QC: 2018-01-25
• Study First Posted: 2018-01-29
• Study Start: 2018-04-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-16
• Last Update Posted: 2020-02-18
• Primary Completion: 2021-03-01
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stentriever Thrombectomy	Stentriever Thrombectomy	-
A Direct Aspiration First Pass Technique	A Direct Aspiration First Pass Technique	-

Primary Outcome Measures

Name	Time	Method
modified rankin scale (mRs) at 90 days [effectiveness]	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 Outcome Measures

Name	Time	Method
Symptomatic intracranial bleeding [safety of the technique]	First 14 days	The rate of patients with intracranial hemorrhage (measured by computed tomography) with worsening of 4 points on the NIHSS scale will be evaluated.
Thrombolysis in cerebral infarction (TICI) scale 2b-3 [effectiveness]	Up to 24 hours after endovascular reperfusion	After endovascular reperfusion technique, TICI score will be evaluated in all consecutive patients. The rate of TICI 2b-3 will be recorded as a effectiveness endpoint.

Trial Locations

Locations (9)

Hospital Universitario de Donostia; 🇪🇸 San Sebastián, Spain

Hospital Clínico Universitario Virgen de la Arrixaca; 🇪🇸 Murcia, Spain

Hospital Universitario Insular de Gran Canaria; 🇪🇸 Las Palmas De Gran Canaria, Spain

Hospital Clínico Universitario; 🇪🇸 Valladolid, Spain

Hospital Universitario Virgen de las Nieves; 🇪🇸 Granada, Spain

Hospital Universitario Marqués de Valdecilla; 🇪🇸 Santander, Spain

Hospital Universitario de Cruces; 🇪🇸 Bilbao, Spain

Hospital Universitario Reina Sofia; 🇪🇸 Córdoba, Spain

Hospital Universitario Central de Asturias; 🇪🇸 Oviedo, Spain