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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04270513
Acronym
FIT
Enrollment
477
Registered
2020-02-17
Start date
2018-02-01
Completion date
2020-04-30
Last updated
2020-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Infarction

Keywords

endovascular treatment, stroke, large vessel occlusion, telemedicine, helicopter, thrombectomy, mobile interventionalist, flying intervention team

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.

Interventions

OTHEREndovascular 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.

Sponsors

Technical University of Munich
CollaboratorOTHER
University of Regensburg
CollaboratorOTHER
Munich Municipal Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Time from decision for endovascular treatment to groin punctureday 1Time from telemedicine-assisted decision for endovascular treatment to initiation of endovascular treatment by groin puncture

Secondary

MeasureTime frameDescription
Other procedural times of hyperacute careday 1Other procedural times between symptom onset, admission to PSC, first imaging, decision for endovascular treatment, initiation of endovascular treatment and completion of endovascular treatment
Recanalizationday 1Proportion of patients with antegrade reperfusion of more than half of the previously occluded target artery ischemic territory after endovascular treatment
Symptomatic intracerebral hemorrhage7 daysProportion of patients with symptomatic intracerebral hemorrhage
Time from symptom onset to recanalizationday 1Time from symptom onset to recanalization of previously occluded target artery by endovascular treatment
Periprocedural complicationsday 1Proportion of patients with periprocedural, endovascular treatment associated complications
In-hospital complications7 daysProportion of patients with other in-hospital complications
In-hospital death or palliative care7 daysIn-hospital death or decision for palliative care

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026