NCT04001738

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
174

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 14, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 28, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2020

Completed
Last Updated

January 5, 2021

Status Verified

December 1, 2020

Enrollment Period

2.2 years

First QC Date

June 26, 2019

Last Update Submit

December 30, 2020

Conditions

Stroke, Acute

Keywords

Endovascular treatmentLarge Vessel Occlusion

Outcome Measures

Primary Outcomes (2)

  • 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).

    90 days

  • Rate of patients with treatment associated complications.

    Lack of treatment associated complications, mainly hemorrhagic transformation.

    72 hours

Secondary Outcomes (4)

  • Delay of inhospital times

    8 hours

  • Rate of dramatic improvement

    24 hours

  • Rate of good functional outcome

    90 days

  • Rate of patients treated by endovascular treatment

    8 hours

Study Arms (2)

Direct Transfer to Angio Suite

ACTIVE COMPARATOR

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

Direct Transfer to CT Scan

NO INTERVENTION

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.

Interventions

Direct Transfer to Angio SuiteOTHER

Patient will be direct transferred to angiography suite where EVT team will be waiting for it.

Direct Transfer to Angio Suite

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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…)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vall d'Hebron University Hospital

Barcelona, Catalonia, 08035, Spain

Location

Related Publications (6)

  • 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.

    PMID: 24281224BACKGROUND

  • 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.

    PMID: 28446535BACKGROUND

  • 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.

    PMID: 28536177BACKGROUND

  • 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.

    PMID: 29018132BACKGROUND

  • 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.

    PMID: 30355182BACKGROUND

  • 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.

    PMID: 34338742DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 26, 2019

First Posted

June 28, 2019

Study Start

August 14, 2018

Primary Completion

November 7, 2020

Study Completion

November 7, 2020

Last Updated

January 5, 2021

Record last verified: 2020-12

Locations

ES(1)