Flying Intervention Team for Endovascular Treatment of Acute Ischemic Stroke in Rural Areas (FIT)

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).

Study Overview

• Status: Unknown
• Conditions: Brain Infarction
• Intervention / Treatment: Other: Endovascular treatment by Flying Intervention Team

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 Type: Observational
• Enrollment (Actual): 477

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 81545
      • TEMPiS TeleStroke Network, Department of Neurology, Munich Municipal Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Acute stroke patients eligible for endovascular treatment initially admitted to participating primary stroke center

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from decision for endovascular treatment to groin puncture	Time from telemedicine-assisted decision for endovascular treatment to initiation of endovascular treatment by groin puncture	day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from symptom onset to recanalization	Time from symptom onset to recanalization of previously occluded target artery by endovascular treatment	day 1
Other procedural times of hyperacute care	Other procedural times between symptom onset, admission to PSC, first imaging, decision for endovascular treatment, initiation of endovascular treatment and completion of endovascular treatment	day 1
Recanalization	Proportion of patients with antegrade reperfusion of more than half of the previously occluded target artery ischemic territory after endovascular treatment	day 1
Symptomatic intracerebral hemorrhage	Proportion of patients with symptomatic intracerebral hemorrhage	7 days
In-hospital death or palliative care	In-hospital death or decision for palliative care	7 days
Periprocedural complications	Proportion of patients with periprocedural, endovascular treatment associated complications	day 1
In-hospital complications	Proportion of patients with other in-hospital complications	7 days

Collaborators and Investigators

• Sponsor: Munich Municipal Hospital
• Collaborators: Technical University of Munich; University of Regensburg
• Investigators: Principal Investigator: Gordian J Hubert, Dr. med., München Klinik gGmbH

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• TEMPIS

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): October 24, 2019
• Study Completion (Anticipated): April 1, 2020

Study Registration Dates

• First Submitted: April 13, 2018
• First Submitted That Met QC Criteria: February 12, 2020
• First Posted (Actual): February 17, 2020

Study Record Updates

• Last Update Posted (Actual): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 12, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: stroke; endovascular treatment; telemedicine; thrombectomy; large vessel occlusion; helicopter; mobile interventionalist; flying intervention team
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Stroke; Infarction; Ischemic Stroke; Brain Infarction
• Other Study ID Numbers: FIT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No