Thrombectomy In ANdalucia Using Aspiration (TRIANA)

NCT03407092 | Completed

• 1 other identifier: PI-0374-2017
• Study Type: observational
• Target: 532
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the efficacy and safety of ADAPT vs Stentriever techique in a multicenter stroke cohort of patients.

Conditions

Stroke, Acute

Outcome Measures

Primary Outcomes (1)

• modified rankin scale (mRs) at 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 1. No significant disability despite symptoms; able to carry out all usual duties and activities 2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. Moderate disability; requiring some help, but able to walk without assistance 4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. Dead

  90 days

Secondary Outcomes (3)

• Symptomatic Intracranial bleeding

  during admission

• Haemorrhagic tranformation

  during admission

• Thrombolysis in cerebral infarction (TICI) scale

  Up to 24 hours after endovascular reperfusion

Study Arms (2)

Stentriever Cohort

Other: Stentriever Cohort

ADAPT cohort

Other: ADAPT cohort

Interventions

ADAPT cohort OTHER

Thrombectomy with distal aspiration technique

ADAPT cohort

Stentriever Cohort OTHER

Thrombectomy with stent retriever

Stentriever Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients with ischemic stroke in which imaging demonstrates a vascular occlusion located in the distal internal carotid artery (ICA) through the distal middle cerebral artery (MCA) who require endovascular reperfusion.

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 years old.
• 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.

Sponsors & Collaborators

• Hospitales Universitarios Virgen del Rocío: lead
• Andaluz Health Service: collaborator

Study Sites (1)

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Alejandro González, Md, PhD

  Hospitales Universitarios Virgen del Rocío

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: January 23, 2018
• Study Start: January 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: February 13, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)