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COmparing CeNters ThRombectomy Aspiration STentretriever (CONTRAST)

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ClinicalTrials.gov Identifier: NCT03412851
Recruitment Status : Recruiting
First Posted : January 29, 2018
Last Update Posted : August 10, 2018
Sponsor:
Information provided by (Responsible Party):
Alejandro González, 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.

Condition or disease Intervention/treatment
Acute Stroke Other: A Direct Aspiration First Pass Technique Other: Stentriever Thrombectomy

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: COmparing CeNters ThRombectomy Aspiration STentretriever
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : June 1, 2021

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




Primary Outcome Measures :
  1. modified rankin scale (mRs) at 90 days [effectiveness] [ Time Frame: 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 :
  1. Symptomatic intracranial bleeding [safety of the technique] [ Time Frame: 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.

  2. Thrombolysis in cerebral infarction (TICI) scale 2b-3 [effectiveness] [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03412851


Contacts
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Contact: Alejandro González, MD, PhD +34 696646686 ggjandro@gmail.com

Locations
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Spain
Hospital Universitario de Cruces Not yet recruiting
Bilbao, Spain
Contact: Alain Luna         
Hospital Universitario Reina Sofia Not yet recruiting
Córdoba, Spain
Contact: Fernando Delgado, MD, PhD         
Hospital Universitario Virgen de las Nieves Not yet recruiting
Granada, Spain
Contact: Pedro Pablo Alcazar, MD, PhD         
Hospital Universitario Insular de Gran Canaria Not yet recruiting
Las Palmas De Gran Canaria, Spain
Contact: Yeray Aguilar, MD         
Hospital Clínico Universitario Virgen de la Arrixaca Recruiting
Murcia, Spain
Contact: Joaquin Zamarro, MD         
Hospital Universitario Central de Asturias Not yet recruiting
Oviedo, Spain
Contact: Pedro Vega, MD         
Hospital Universitario de Donostia Not yet recruiting
San Sebastián, Spain
Contact: Pedro Navia, MD         
Hospital Universitario Marqués de Valdecilla Not yet recruiting
Santander, Spain
Contact: Andrés González Mandly, MD         
Hospital Clínico Universitario Not yet recruiting
Valladolid, Spain
Contact: Juan Arenillas, MD, PhD         
Sponsors and Collaborators
Hospitales Universitarios Virgen del Rocío
Investigators
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Principal Investigator: Alejandro González, MD, PhD Hospitales Universitarios Virgen del Rocío

Additional Information:

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Responsible Party: Alejandro González, Principal Investigator, Hospitales Universitarios Virgen del Rocío
ClinicalTrials.gov Identifier: NCT03412851     History of Changes
Other Study ID Numbers: CO-18-V1.0
First Posted: January 29, 2018    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alejandro González, Hospitales Universitarios Virgen del Rocío:
Thrombectomy
Stentriever
ADAPT
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases