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

Primary Purpose

Stroke, Acute

Status
Terminated
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Direct Transfer to Angio Suite
Sponsored by
Hospital Vall d'Hebron
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Acute focused on measuring Endovascular treatment, Large Vessel Occlusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Vall d'Hebron University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Direct Transfer to Angio Suite

Direct Transfer to CT Scan

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Clinical outcome measurde by modified Rankin Scale score (shift analysis)
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).
Rate of patients with treatment associated complications.
Lack of treatment associated complications, mainly hemorrhagic transformation.

Secondary Outcome Measures

Delay of inhospital times
Time from door to groin puncture
Rate of dramatic improvement
10 NIHSS points drop or NIHSS <2
Rate of good functional outcome
Modified Rankin Scale score ≤2
Rate of patients treated by endovascular treatment

Full Information

First Posted
June 26, 2019
Last Updated
December 30, 2020
Sponsor
Hospital Vall d'Hebron
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1. Study Identification

Unique Protocol Identification Number
NCT04001738
Brief Title
Evaluation of Direct Transfer to Angiography Suite vs. Computed Tomography Suite in Endovascular Treatment: Randomized Clinical Trial (ANGIOCAT)
Acronym
ANGIOCAT
Official Title
Evaluation of Direct Transfer to Angiography Suite vs. Computed Tomography Suite in Endovascular Treatment: Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Terminated
Why Stopped
Intermediate analysis
Study Start Date
August 14, 2018 (Actual)
Primary Completion Date
November 7, 2020 (Actual)
Study Completion Date
November 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Vall d'Hebron

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute
Keywords
Endovascular treatment, Large Vessel Occlusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
174 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Direct Transfer to Angio Suite
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Direct Transfer to CT Scan
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Direct Transfer to Angio Suite
Intervention Description
Patient will be direct transferred to angiography suite where EVT team will be waiting for it.
Primary Outcome Measure Information:
Title
Clinical outcome measurde by modified Rankin Scale score (shift analysis)
Description
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).
Time Frame
90 days
Title
Rate of patients with treatment associated complications.
Description
Lack of treatment associated complications, mainly hemorrhagic transformation.
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Delay of inhospital times
Description
Time from door to groin puncture
Time Frame
8 hours
Title
Rate of dramatic improvement
Description
10 NIHSS points drop or NIHSS <2
Time Frame
24 hours
Title
Rate of good functional outcome
Description
Modified Rankin Scale score ≤2
Time Frame
90 days
Title
Rate of patients treated by endovascular treatment
Time Frame
8 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Vall d'Hebron University Hospital
City
Barcelona
State/Province
Catalonia
ZIP/Postal Code
08035
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24281224
Citation
Perez de la Ossa N, Carrera D, Gorchs M, Querol M, Millan M, Gomis M, Dorado L, Lopez-Cancio E, Hernandez-Perez M, Chicharro V, Escalada X, Jimenez X, Davalos A. Design and validation of a prehospital stroke scale to predict large arterial occlusion: the rapid arterial occlusion evaluation scale. Stroke. 2014 Jan;45(1):87-91. doi: 10.1161/STROKEAHA.113.003071. Epub 2013 Nov 26.
Results Reference
background
PubMed Identifier
28446535
Citation
Ribo M, Boned S, Rubiera M, Tomasello A, Coscojuela P, Hernandez D, Pagola J, Juega J, Rodriguez N, Muchada M, Rodriguez-Luna D, Molina CA. Direct transfer to angiosuite to reduce door-to-puncture time in thrombectomy for acute stroke. J Neurointerv Surg. 2018 Mar;10(3):221-224. doi: 10.1136/neurintsurg-2017-013038. Epub 2017 Apr 26.
Results Reference
background
PubMed Identifier
28536177
Citation
Jadhav AP, Kenmuir CL, Aghaebrahim A, Limaye K, Wechsler LR, Hammer MD, Starr MT, Molyneaux BJ, Rocha M, Guyette FX, Martin-Gill C, Ducruet AF, Gross BA, Jankowitz BT, Jovin TG. Interfacility Transfer Directly to the Neuroangiography Suite in Acute Ischemic Stroke Patients Undergoing Thrombectomy. Stroke. 2017 Jul;48(7):1884-1889. doi: 10.1161/STROKEAHA.117.016946. Epub 2017 May 23.
Results Reference
background
PubMed Identifier
29018132
Citation
Psychogios MN, Behme D, Schregel K, Tsogkas I, Maier IL, Leyhe JR, Zapf A, Tran J, Bahr M, Liman J, Knauth M. One-Stop Management of Acute Stroke Patients: Minimizing Door-to-Reperfusion Times. Stroke. 2017 Nov;48(11):3152-3155. doi: 10.1161/STROKEAHA.117.018077. Epub 2017 Oct 10.
Results Reference
background
PubMed Identifier
30355182
Citation
Mendez B, Requena M, Aires A, Martins N, Boned S, Rubiera M, Tomasello A, Coscojuela P, Muchada M, Rodriguez-Luna D, Rodriguez-Villatoro N, Juega J, Pagola J, Molina CA, Ribo M. Direct Transfer to Angio-Suite to Reduce Workflow Times and Increase Favorable Clinical Outcome. Stroke. 2018 Nov;49(11):2723-2727. doi: 10.1161/STROKEAHA.118.021989.
Results Reference
background
PubMed Identifier
34338742
Citation
Requena M, Olive-Gadea M, Muchada M, Hernandez D, Rubiera M, Boned S, Pinana C, Deck M, Garcia-Tornel A, Diaz-Silva H, Rodriguez-Villatoro N, Juega J, Rodriguez-Luna D, Pagola J, Molina C, Tomasello A, Ribo M. Direct to Angiography Suite Without Stopping for Computed Tomography Imaging for Patients With Acute Stroke: A Randomized Clinical Trial. JAMA Neurol. 2021 Sep 1;78(9):1099-1107. doi: 10.1001/jamaneurol.2021.2385.
Results Reference
derived

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

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