FIT: Flying Intervention Team for Endovascular Treatment of Acute Ischemic Stroke in Rural Areas
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| EVT by Flying Intervention Team in primary stroke center Patients with ischemic stroke and large vessel occlusion admitted to a primary stroke center, for whom a Flying Intervention Team is flown to the primary stroke center in order to perform endovascular treatment. |
Other: Endovascular treatment by Flying Intervention Team
After telemedicine-assisted decision for endovascular treatment, the Flying Intervention Team is transferred via helicopter to the primary stroke center and performs endovascular treatment in the local angiography suite.
|
| EVT after secondary transfer to comprehensive stroke center Patients with ischemic stroke and large vessel occlusion admitted to a primary stroke center, who are transferred to a comprehensive stroke center for endovascular treatment. |
Outcome Measures
Primary Outcome Measures
- Time from decision for endovascular treatment to groin puncture [day 1]
Time from telemedicine-assisted decision for endovascular treatment to initiation of endovascular treatment by groin puncture
Secondary Outcome Measures
- Time from symptom onset to recanalization [day 1]
Time from symptom onset to recanalization of previously occluded target artery by endovascular treatment
- Other procedural times of hyperacute care [day 1]
Other procedural times between symptom onset, admission to PSC, first imaging, decision for endovascular treatment, initiation of endovascular treatment and completion of endovascular treatment
- Recanalization [day 1]
Proportion of patients with antegrade reperfusion of more than half of the previously occluded target artery ischemic territory after endovascular treatment
- Symptomatic intracerebral hemorrhage [7 days]
Proportion of patients with symptomatic intracerebral hemorrhage
- In-hospital death or palliative care [7 days]
In-hospital death or decision for palliative care
- Periprocedural complications [day 1]
Proportion of patients with periprocedural, endovascular treatment associated complications
- In-hospital complications [7 days]
Proportion of patients with other in-hospital complications
Eligibility Criteria
Criteria
Inclusion criteria:
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Admission to participating primary stroke center (PSC) with acute symptoms of stroke
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Telemedicine-supported decision for endovascular treatment (EVT)
Inclusion criteria for primary study population:
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Occlusion of M1, proximal M2, intracranial internal carotid artery (ICA) or basilar artery
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Decision for EVT between 8 a.m. an 10 p.m.
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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)
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Endovascular treatment in PSC by Flying Intervention Team or in comprehensive stroke center after secondary transfer
Exclusion criteria for primary study population:
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Age > 85 years
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Alberta Stroke Program Early CT score (ASPECTS) < 6
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Premorbid severe or moderately severe disability (modified Rankin Scale > 3)
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Premorbid serious or advanced illness with high mortality
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | TEMPiS TeleStroke Network, Department of Neurology, Munich Municipal Hospital | Munich | Bavaria | Germany | 81545 |
Sponsors and Collaborators
- Munich Municipal Hospital
- Technische Universität München
- University of Regensburg
Investigators
- Principal Investigator: Gordian J Hubert, Dr. med., München Klinik gGmbH
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 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.
- 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, Castaño C, Sapkota BL, Fransen PS, Molina C, van Oostenbrugge RJ, Chamorro Á, 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.
- FIT