ClinicalTrials.gg
Status unknownNCT04270513FITUpdated Feb 17, 2020

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

An observational study in Brain Infarction, sponsored by Munich Municipal Hospital. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-17.

Sponsored by Munich Municipal Hospital · Observational

The sponsor has not verified this record recently (last verified Feb 2020), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
477
Ages
18 Years and older
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Brain Infarction

Keywords

  • endovascular treatment
  • stroke
  • large vessel occlusion
  • telemedicine
  • helicopter
  • thrombectomy
  • mobile interventionalist
  • flying intervention team
03

In context

Brain Infarction

93 studies on the registry are indexed under Brain Infarction; 19 are open to participants now.

This study's enrollment of 477 is close to the median of 477 across 23 observational studies indexed under Brain Infarction.

Browse Brain Infarction studies →

Lead sponsor

Munich Municipal Hospital is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
477 participants (actual)
Target follow-up
3 Months
Patient registry
Yes

Groups and cohorts

  • 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

  • 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.

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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: day 1

Secondary outcomes

  1. Time from symptom onset to recanalization

    Time from symptom onset to recanalization of previously occluded target artery by endovascular treatment

    Time frame: day 1

  2. 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

    Time frame: day 1

  3. Recanalization

    Proportion of patients with antegrade reperfusion of more than half of the previously occluded target artery ischemic territory after endovascular treatment

    Time frame: day 1

  4. Symptomatic intracerebral hemorrhage

    Proportion of patients with symptomatic intracerebral hemorrhage

    Time frame: 7 days

  5. In-hospital death or palliative care

    In-hospital death or decision for palliative care

    Time frame: 7 days

  6. Periprocedural complications

    Proportion of patients with periprocedural, endovascular treatment associated complications

    Time frame: day 1

  7. In-hospital complications

    Proportion of patients with other in-hospital complications

    Time frame: 7 days

07

Study locations

1 site
  • TEMPiS TeleStroke Network, Department of Neurology, Munich Municipal Hospital
    Munich, Bavaria 81545, Germany
08

References and documents

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. PubMed 27673305 ↗
  • 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. PubMed 31310296 ↗
  • 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. PubMed 33849042 ↗

Related links

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2018 to primary completion in Oct 2019, 20 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 13, 2018
First posted
Feb 17, 2020
StartActual
Feb 1, 2018
Primary completionActual
Oct 24, 2019
CompletionEst.
Apr 2020
Last update
Feb 17, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04270513
Lead sponsor
Munich Municipal Hospital
Collaborators
Technical University of Munich, University of Regensburg
Responsible party
Sponsor
First posted
Feb 17, 2020
Start date
Feb 1, 2018
Primary completion
Oct 24, 2019
Completion
Apr 2020 (estimated)
Last update
Feb 17, 2020

Study contacts

Gordian J Hubert, Dr. med.
principal investigator · München Klinik gGmbH

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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