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

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ClinicalTrials.gov Identifier: NCT04001738
Recruitment Status : Terminated (Intermediate analysis)
First Posted : June 28, 2019
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
Manuel Requena Ruiz, Hospital Vall d'Hebron

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stroke, Acute Other: Direct Transfer to Angio Suite Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Direct Transfer to Angiography Suite vs. Computed Tomography Suite in Endovascular Treatment: Randomized Clinical Trial
Actual Study Start Date : August 14, 2018
Actual Primary Completion Date : November 7, 2020
Actual Study Completion Date : November 7, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CT Scans

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.



Primary Outcome Measures :
  1. 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).


  2. Rate of patients with treatment associated complications. [ Time Frame: 72 hours ]
    Lack of treatment associated complications, mainly hemorrhagic transformation.


Secondary Outcome Measures :
  1. Delay of inhospital times [ Time Frame: 8 hours ]
    Time from door to groin puncture

  2. Rate of dramatic improvement [ Time Frame: 24 hours ]
    10 NIHSS points drop or NIHSS <2

  3. Rate of good functional outcome [ Time Frame: 90 days ]
    Modified Rankin Scale score ≤2

  4. Rate of patients treated by endovascular treatment [ Time Frame: 8 hours ]


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

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.

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): NCT04001738


Locations
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Spain
Vall d'Hebron University Hospital
Barcelona, Catalonia, Spain, 08035
Sponsors and Collaborators
Hospital Vall d'Hebron
Publications:

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Responsible Party: Manuel Requena Ruiz, Principal Investigator, Hospital Vall d'Hebron
ClinicalTrials.gov Identifier: NCT04001738    
Other Study ID Numbers: PR(AG)156/2018
First Posted: June 28, 2019    Key Record Dates
Last Update Posted: January 5, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Manuel Requena Ruiz, Hospital Vall d'Hebron:
Endovascular treatment
Large Vessel Occlusion
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases