Clinical trial NCT04270513: Flying Intervention Team for Endovascular Treatment of Acute Ischemic Stroke in Rural Areas
Official title: Flying Intervention Team for Endovascular Treatment of Acute Ischemic Stroke in Rural Areas
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Brain Infarction
Keywords: endovascular treatment
stroke
large vessel occlusion
telemedicine
helicopter
thrombectomy
mobile interventionalist
flying intervention team
Lead sponsor: Munich Municipal Hospital
Sponsor class: OTHER
Collaborators: name: Technical University of Munich
name: University of Regensburg
First posted: 2020-02-17
Enrollment: 477
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Acute stroke patients eligible for endovascular treatment initially admitted to participating primary stroke center

Brief summary: The aim of this study is to compare time delay and safety parameters of stroke patients initially admitted to a rural primary stroke center (PSC) who receive endovascular treatment (EVT) by a Flying Intervention Team with patients who receive EVT after secondary transfer to a comprehensive stroke center (CSC).

Detailed description: A novel health care concept was implemented in the telemedical stroke network TEMPiS (Telemedical Project for integrative Stroke Care) to reduce time delays to EVT in stroke patients with large vessel occlusion: After telemedicine-assisted identification of EVT candidates in a PSC, a Flying Intervention Team (neuroradiologist and angiography assistant) is flown from a CSC via helicopter to the PSC to perform EVT in the local angiography suite. Flying Intervention Team service runs from 8 a.m. to 10 p.m. Patients remain at local stroke unit for further treatment.

Analysis will include time delay to EVT, recanalization, symptomatic intracerebral hemorrhage, periprocedural complications, in-hospital complications, and mortality.

Eligibility criteria: Inclusion criteria:

* Admission to participating primary stroke center (PSC) with acute symptoms of stroke
* Telemedicine-supported decision for endovascular treatment (EVT)

Inclusion criteria for primary study population:

* Occlusion of M1, proximal M2, intracranial internal carotid artery (ICA) or basilar artery
* Decision for EVT between 8 a.m. an 10 p.m.
* Time from symptom onset to EVT decision within treatment window (0-6 h for M1, M2 and ICA occlusions, 0-24 h for basilar artery occlusions, 0-24 for M1, M2 and ICA occlusions with suitable mismatch in perfusion imaging performed in PSC)
* Endovascular treatment in PSC by Flying Intervention Team or in comprehensive stroke center after secondary transfer

Exclusion criteria for primary study population:

* Age \> 85 years
* Alberta Stroke Program Early CT score (ASPECTS) \< 6
* Premorbid severe or moderately severe disability (modified Rankin Scale \> 3)
* Premorbid serious or advanced illness with high mortality

Primary outcomes:
measure: Time from decision for endovascular treatment to groin puncture
timeFrame: day 1
Secondary outcomes:
measure: Time from symptom onset to recanalization
timeFrame: day 1
measure: Other procedural times of hyperacute care
timeFrame: day 1
measure: Recanalization
timeFrame: day 1
measure: Symptomatic intracerebral hemorrhage
timeFrame: 7 days
measure: In-hospital death or palliative care
timeFrame: 7 days
measure: Periprocedural complications
timeFrame: day 1
measure: In-hospital complications
timeFrame: 7 days
Other outcomes:
Locations:
city: Munich
country: Germany
facility: TEMPiS TeleStroke Network, Department of Neurology, Munich Municipal Hospital
state: Bavaria
Study officials:
affiliation: München Klinik gGmbH
name: Gordian J Hubert, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Saver JL, Goyal M, van der Lugt A, Menon BK, Majoie CB, Dippel DW, Campbell BC, Nogueira RG, Demchuk AM, Tomasello A, Cardona P, Devlin TG, Frei DF, du Mesnil de Rochemont R, Berkhemer OA, Jovin TG, Siddiqui AH, van Zwam WH, Davis SM, Castano C, Sapkota BL, Fransen PS, Molina C, van Oostenbrugge RJ, Chamorro A, Lingsma H, Silver FL, Donnan GA, Shuaib A, Brown S, Stouch B, Mitchell PJ, Davalos A, Roos YB, Hill MD; HERMES Collaborators. Time to Treatment With Endovascular Thrombectomy and Outcomes From Ischemic Stroke: A Meta-analysis. JAMA. 2016 Sep 27;316(12):1279-88. doi: 10.1001/jama.2016.13647.
citation: Jahan R, Saver JL, Schwamm LH, Fonarow GC, Liang L, Matsouaka RA, Xian Y, Holmes DN, Peterson ED, Yavagal D, Smith EE. Association Between Time to Treatment With Endovascular Reperfusion Therapy and Outcomes in Patients With Acute Ischemic Stroke Treated in Clinical Practice. JAMA. 2019 Jul 16;322(3):252-263. doi: 10.1001/jama.2019.8286.
citation: Hubert GJ, Kraus F, Maegerlein C, Platen S, Friedrich B, Kain HU, Witton-Davies T, Hubert ND, Zimmer C, Bath PM, Audebert HJ, Haberl RL. The "Flying Intervention Team": A Novel Stroke Care Concept for Rural Areas. Cerebrovasc Dis. 2021;50(4):375-382. doi: 10.1159/000514845. Epub 2021 Apr 13.