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

Stroke, Acute Clinical Trial

— ANGIOCAT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04001738
• Other study ID #: PR(AG)156/2018
• Status: Terminated
• Phase: N/A
• Start date: August 14, 2018
• Est. completion date: November 7, 2020

Study information

• Verified date: December 2020
• Source: Hospital Vall d'Hebron
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 174
• Est. completion date: November 7, 2020
• Est. primary completion date: November 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke
• Stroke, Acute

Intervention

Other:
• Direct Transfer to Angio Suite
Patient will be direct transferred to angiography suite where EVT team will be waiting for it.

Locations

Country	Name	City	State
Spain	Vall d'Hebron University Hospital	Barcelona	Catalonia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Vall d'Hebron

Country where clinical trial is conducted

Spain, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Rate of patients with treatment associated complications.	Lack of treatment associated complications, mainly hemorrhagic transformation.	72 hours
Secondary	Delay of inhospital times	Time from door to groin puncture	8 hours
Secondary	Rate of dramatic improvement	10 NIHSS points drop or NIHSS <2	24 hours
Secondary	Rate of good functional outcome	Modified Rankin Scale score =2	90 days
Secondary	Rate of patients treated by endovascular treatment		8 hours