COmparing CeNters ThRombectomy Aspiration STentretriever
CONTRAST
1 other identifier
observational
1,000
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2018
Typical duration for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2018
CompletedFirst Posted
Study publicly available on registry
January 29, 2018
CompletedStudy Start
First participant enrolled
April 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedFebruary 18, 2020
February 1, 2020
2.9 years
January 12, 2018
February 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
modified rankin scale (mRs) at 90 days [effectiveness]
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 \[Time Frame: 90 days\]
90 days
Secondary Outcomes (2)
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
Study Arms (2)
A Direct Aspiration First Pass Technique
Stentriever Thrombectomy
Interventions
Distal aspiration technique
Eligibility Criteria
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).
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Hospital Universitario de Cruces
Bilbao, Spain
Hospital Universitario Reina Sofia
Córdoba, Spain
Hospital Universitario Virgen de las Nieves
Granada, Spain
Hospital Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, Spain
Hospital Universitario Central de Asturias
Oviedo, Spain
Hospital Universitario de Donostia
San Sebastián, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Spain
Hospital Clínico Universitario
Valladolid, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alejandro González, MD, PhD
Hospitales Universitarios Virgen del Rocío
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 12, 2018
First Posted
January 29, 2018
Study Start
April 1, 2018
Primary Completion
March 1, 2021
Study Completion
June 1, 2021
Last Updated
February 18, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share