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

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

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.

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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 ]

Eligibility Criteria

• 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.

Contacts and Locations

Locations

Spain

Vall d'Hebron University Hospital

Barcelona, Catalonia, Spain, 08035

Sponsors and Collaborators

Hospital Vall d'Hebron

More Information

Publications:

Pérez de la Ossa N, Carrera D, Gorchs M, Querol M, Millán M, Gomis M, Dorado L, López-Cancio E, Hernández-Pérez M, Chicharro V, Escalada X, Jiménez X, Dávalos 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.

Ribo M, Boned S, Rubiera M, Tomasello A, Coscojuela P, Hernández 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.

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.

Psychogios MN, Behme D, Schregel K, Tsogkas I, Maier IL, Leyhe JR, Zapf A, Tran J, Bähr 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.

Mendez B, Requena M, Aires A, Martins N, Boned S, Rubiera M, Tomasello A, Coscojuela P, Muchada M, Rodríguez-Luna D, Rodríguez-Villatoro N, Juega J, Pagola J, Molina CA, Ribó 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.

• 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
• Last Update Posted: January 5, 2021
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• 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:

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases