Evaluation of Direct Transfer to Angiography Suite vs. Computed Tomography Suite in Endovascular Treatment: Randomized Clinical Trial (ANGIOCAT) (ANGIOCAT)

December 30, 2020 updated by: Manuel Requena Ruiz, Hospital Vall d'Hebron

Evaluation of Direct Transfer to Angiography Suite vs. Computed Tomography Suite in Endovascular Treatment: Randomized Clinical Trial

To evaluate the hypothesis that an ultra-fast triage with one-stop in angiography suite based on cone-beam CT compared to traditional protocol offers a better outcome in the distribution of the modified Rankin Scale scores at 90 days in acute ischemic stroke patients with suspected large vessel occlusion (LVO) within 6 hours from symptoms onset.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Prospective, randomized, open, treatment-blinded trial of acute stroke patients with suspected large vessel occlusion within 6 hours from symptoms onset in which two strategies will be compared: Direct Transfer to Angiography Suite (DTAS) vs. Computed Tomography Suite (DTCT). The study will be unicentric however there is the possibility of incorporating new stroke centers with previous experience of at least 50 DTAS cases.

The RACE scale (Rapid Arterial oCclusion Evaluation) will be used as a prehospital screening tool to identify acute stroke patients with suspicion of LVO. Once prenotifying the imminent arrival and the verified inclusion and exclusion criteria by the Neurologist at arrival, the patient will be randomized by an app in one of both study protocols.

Subjects will be followed up to 90 days post-randomization.

Study Type

Interventional

Enrollment (Actual)

174

Phase

  • Not Applicable

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
    • Catalonia
      • Barcelona, Catalonia, Spain, 08035
        • Vall d'Hebron University Hospital

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

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Large vessel occlusion suspected acute stroke codes (RACE>4) within 6 hours from stroke onset which are prenotified from emergency medical system.
  • Confirmed NIHSS>10 at arrival.
  • Good pre-stroke functional status (mRS≤2)
  • Angiography suite available.
  • Endovascular treatment team available (Neurologist, Interventionist, anesthesiologist, Nursery, Technicians…)

Exclusion Criteria:

  • Hemodynamically unstable patients who requires of advanced vital support.
  • Patients with an advanced disease that conditions a life expectancy lower than 6 months.
  • Participation in other clinical trial with a drug or device which could influence in the outcome.
  • Patients with neurological or psychiatric disease that could confound future evaluations.
  • Lack of disponibility for 90 days tracing.

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Direct Transfer to Angio Suite
After a fast neurological evaluation, patient will be direct transferred to angiography suite where endovascular treatment (EVT) team will be waiting for it. It will be done a cone beam-CT and if the image don't contraindicate endovascular treatment it will be performed and the large vessel occlusion will be confirmed by arteriography. If intravenous treatment have not been previously administered, it will be able to start in parallel.
Other: Direct Transfer to Angio Suite
Patient will be direct transferred to angiography suite where EVT team will be waiting for it.
NO_INTERVENTION: Direct Transfer to CT Scan
After a fast neurological evaluation, patient will be transferred to CT suite where usual image protocol will be performed (CT and CT-angio). Within 6 hours from onset CT perfusion could be required to take detections. Once interpreted image results, it will be decided intravenous and/or endovascular treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical outcome measurde by modified Rankin Scale score (shift analysis)
Time Frame: 90 days

Modified Rankin Scale score in ischemic stroke patients with large vessel occlusion as evaluated through a structured telephone-based interview performed by a central assessor who is blinded to group assignment.

Modified Rankin Scale measures functional status with a range from 0 (asymptomatic) to 6 (dead).
90 days
Rate of patients with treatment associated complications.
Time Frame: 72 hours
Lack of treatment associated complications, mainly hemorrhagic transformation.
72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delay of inhospital times
Time Frame: 8 hours
Time from door to groin puncture
8 hours
Rate of dramatic improvement
Time Frame: 24 hours
10 NIHSS points drop or NIHSS <2
24 hours
Rate of good functional outcome
Time Frame: 90 days
Modified Rankin Scale score ≤2
90 days
Rate of patients treated by endovascular treatment
Time Frame: 8 hours
8 hours

Collaborators and Investigators

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

Sponsor

Hospital Vall d'Hebron

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 14, 2018

Primary Completion (ACTUAL)

November 7, 2020

Study Completion (ACTUAL)

November 7, 2020

Study Registration Dates

First Submitted

June 26, 2019

First Submitted That Met QC Criteria

June 27, 2019

First Posted (ACTUAL)

June 28, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 5, 2021

Last Update Submitted That Met QC Criteria

December 30, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR(AG)156/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

Clinical Trials on Stroke, Acute

Clinical Trials on Direct Transfer to Angio Suite

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Denmark

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe