COmparing CeNters ThRombectomy Aspiration STentretriever (CONTRAST)

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.

Study Overview

• Status: Unknown
• Conditions: Acute Stroke
• Intervention / Treatment: Other: A Direct Aspiration First Pass Technique; Other: Stentriever Thrombectomy

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Alejandro González, MD, PhD; Phone Number: +34 696646686; Email: ggjandro@gmail.com

Study Locations

• Spain
  • Bilbao, Spain
    • Not yet recruiting
    • Hospital Universitario de Cruces
    • Contact: Alain Luna
  • Córdoba, Spain
    • Not yet recruiting
    • Hospital Universitario Reina Sofia
    • Contact: Fernando Delgado, MD, PhD
  • Granada, Spain
    • Not yet recruiting
    • Hospital Universitario Virgen de las Nieves
    • Contact: Pedro Pablo Alcazar, MD, PhD
  • Las Palmas De Gran Canaria, Spain
    • Not yet recruiting
    • Hospital Universitario Insular de Gran Canaria
    • Contact: Yeray Aguilar, MD
  • Murcia, Spain
    • Recruiting
    • Hospital Clínico Universitario Virgen de la Arrixaca
  • Oviedo, Spain
    • Not yet recruiting
    • Hospital Universitario Central de Asturias
    • Contact: Pedro Vega, MD
  • San Sebastián, Spain
    • Not yet recruiting
    • Hospital Universitario de Donostia
    • Contact: Pedro Navia, MD
  • Santander, Spain
    • Not yet recruiting
    • Hospital Universitario Marques de Valdecilla
    • Contact: Andrés González Mandly, MD
  • Valladolid, Spain
    • Not yet recruiting
    • Hospital Clinico Universitario
    • Contact: Juan Arenillas, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
A Direct Aspiration First Pass Technique	Other: A Direct Aspiration First Pass Technique; Distal aspiration technique
Stentriever Thrombectomy	Other: Stentriever Thrombectomy; Thrombectomy with stent retriever

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptomatic intracranial bleeding [safety of the technique]	The rate of patients with intracranial hemorrhage (measured by computed tomography) with worsening of 4 points on the NIHSS scale will be evaluated.	First 14 days
Thrombolysis in cerebral infarction (TICI) scale 2b-3 [effectiveness]	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.	Up to 24 hours after endovascular reperfusion

Collaborators and Investigators

• Sponsor: Hospitales Universitarios Virgen del Rocío
• Investigators: Principal Investigator: Alejandro González, Md, PhD, Hospitales Universitarios Virgen del Rocío

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Anticipated): March 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: January 12, 2018
• First Submitted That Met QC Criteria: January 25, 2018
• First Posted (Actual): January 29, 2018

Study Record Updates

• Last Update Posted (Actual): February 18, 2020
• Last Update Submitted That Met QC Criteria: February 16, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Thrombectomy; ADAPT; Stentriever
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: CO-18-V1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No