Thrombectomy In ANdalucia Using Aspiration (TRIANA) (TRIANA)

February 11, 2020 updated by: Alejandro González, Hospitales Universitarios Virgen del Rocío
This study aims to compare the efficacy and safety of ADAPT vs Stentriever techique in a multicenter stroke cohort of patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In Andalusia, current data show that the mortality rate from stroke is 50% higher than in Spain as a whole. Endovascular therapy has revolutionized the treatment of acute stroke and could improve these high mortality rates. The investigators propose to take the great advance that the thrombectomy has given to the community of Andalusia in which there are more limited resources with several strategies such as the implementation of strict protocols of inclusion through a common registry, use of cheaper equipment (aspiration vs stent-retrievers)

The objective of the TRIANA trial is thus to:

1. Demonstrate that the use of thrombectomy systems with direct aspiration first pass technique (ADAPT ) using the new large-bore 6F SOFIA Plus catheter (MicroVention, Inc., a wholly owned subsidiary of Terumo Corporation) is equal in safety and efficacy to the results of thrombectomy with stent retriever.

2) The use of mechanical aspiration systems would lead to a decrease in cost per procedure, shortening the duration of treatment and decrease the rate of embolism to new territory.

3) Identify futile recanalization blood biomarkers that will allow the investigators in the future to treat only those patients who will benefit from the most adequate reperfusion treatment.

The design is an observational, prospective and multicentric study of patients with acute ischemic stroke of anterior circulation and less than 8 hours of evolution treated with neurointerventionist rescue techniques to study safety, effectiveness, costs of the intervention and duration (puncture-recanalization) of the thrombectomy system with aspiration with Sofia Plus in comparison with the stent retrievers system.

  1. To evaluate the safety and effectiveness of thrombectomy with manual mechanical aspiration with Sofia Plus under clinical practice conditions.
  2. Determine if the duration (puncture-recanalization) of thrombectomy with aspiration is less than that of stents retrievers; And if the number of embolisms distal to new vascular territories decreases with aspiration.
  3. To estimate the cost savings by procedure in the treatment of ischemic stroke and to analyze the efficiency (cost effectiveness) of thrombectomy with aspiration.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
532

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

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 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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Stentriever Cohort
Other: Stentriever Cohort
Thrombectomy with stent retriever
ADAPT cohort
Other: ADAPT cohort
Thrombectomy with distal aspiration technique

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
modified rankin scale (mRs) at 90 days
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

  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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Symptomatic Intracranial bleeding
Time Frame: during admission
during admission
Haemorrhagic tranformation
Time Frame: during admission
Haemorrhagic tranformation in control computed tomography after thrombectomy.
during admission
Thrombolysis in cerebral infarction (TICI) scale
Time Frame: Up to 24 hours after endovascular reperfusion

It´s a tool for determining the response of thrombolytic/thrombectomy therapy for ischaemic stroke. In neurointerventional radiology it is commonly used for patients post endovascular revascularisation. Like most therapy response grading systems, it predicts prognosis.

Classification

The description is based on the angiographic appearances of the treated occluded vessel and the distal branches:

Grade 0: no perfusion Grade 1: penetration with minimal perfusion Grade 2: partial perfusion Grade 2A: only partial filling (less than two-thirds) of the entire vascular territory is visualized Grade 2B: complete filling of all of the expected vascular territory is visualized but the filling is slower than normal Grade 3: complete perfusion
Up to 24 hours after endovascular reperfusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospitales Universitarios Virgen del Rocío

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Andaluz Health Service

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alejandro González, Md, PhD, Hospitales Universitarios Virgen del Rocío

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 12, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 13, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PI-0374-2017

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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