Brain InfarctionFITNCT04270513
Flying Intervention Team for Endovascular Treatment of Acute Ischemic Stroke in Rural Areas
An observational study of Brain Infarction, run by Munich Municipal Hospital at 1 site in Germany.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Infarction
- What is being tested?
- Endovascular treatment by Flying Intervention Team
- How many people
- 477 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2018to Apr 2020
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute stroke patients eligible for endovascular treatment initially admitted to participating primary stroke center
Who may be able to join
- Admission to participating primary stroke center (PSC) with acute symptoms of stroke
- Telemedicine-supported decision for endovascular treatment (EVT)
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
TEMPiS TeleStroke Network, Department of Neurology, Munich Municipal Hospital
Munich, Bavaria, 81545
About this study
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.
- Conditions
- Brain Infarction
- Being tested
- Endovascular treatment by Flying Intervention Team
- Keywords
- endovascular treatment, stroke, large vessel occlusion, telemedicine, helicopter, thrombectomy, mobile interventionalist, flying intervention team
- Medical subject headings
- Brain Infarction, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular treatment by Flying Intervention TeamOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: day 1
Secondary outcomes (7)
Time from symptom onset to recanalization
Time from symptom onset to recanalization of previously occluded target artery by endovascular treatment
Measured: 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
Measured: day 1
Recanalization
Proportion of patients with antegrade reperfusion of more than half of the previously occluded target artery ischemic territory after endovascular treatment
Measured: day 1
Symptomatic intracerebral hemorrhage
Proportion of patients with symptomatic intracerebral hemorrhage
Measured: 7 days
In-hospital death or palliative care
In-hospital death or decision for palliative care
Measured: 7 days
Periprocedural complications
Proportion of patients with periprocedural, endovascular treatment associated complications
Measured: day 1
In-hospital complications
Proportion of patients with other in-hospital complications
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start1 Feb 2018
- Primary completion24 Oct 2019
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Brain InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 477 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Munich Municipal Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Technical University of Munich, University of Regensburg
- Responsible party
- Sponsor
- Investigators
- Gordian J Hubert, Dr. med., Principal investigator, München Klinik gGmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04270513
- Sponsor's protocol ID
- FIT
- Acronym
- FIT
- Status last verified
- Feb 2020
- First submitted
- 13 Apr 2018
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 27673305Jahan 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 31310296Leitner MA, Hubert GJ, Paternoster L, Leitner MI, Remi JM, Trumm C, Haberl RL, Hubert ND. Clinical outcome of rural in-hospital-stroke patients after interhospital transfer for endovascular therapy within a telemedical stroke network in Germany: a registry-based observational study. BMJ Open. 2024 Jan 18;14(1):e071975. doi: 10.1136/bmjopen-2023-071975.
PubMed 38238050Hubert 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flying Intervention Team for Endovascular Treatment of Acute Ischemic Stroke in Rural Areas
- ClinicalTrials.gov ID
- NCT04270513
- Acronym / sponsor ID
- FIT / FIT
- Conditions
- Brain Infarction
- Keywords
- endovascular treatment, stroke, large vessel occlusion, telemedicine, helicopter, thrombectomy, mobile interventionalist, flying intervention team
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 477 participants (actual)
- Lead sponsor
- Munich Municipal HospitalUniversity, hospital or other
- Collaborators
- Technical University of Munich, University of Regensburg
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 24 Oct 2019 (actual)
- Study completion
- Apr 2020 (estimated)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EVT by Flying Intervention Team in primary stroke center | – | Other: Endovascular treatment by Flying Intervention TeamPatients 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute stroke patients eligible for endovascular treatment initially admitted to participating primary stroke center
Key inclusion criteria (6 listed)
- Admission to participating primary stroke center (PSC) with acute symptoms of stroke
- Telemedicine-supported decision for endovascular treatment (EVT)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular treatment by Flying Intervention TeamAfter 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. | Other | EVT by Flying Intervention Team in primary stroke center |
Primary outcome
Time from decision for endovascular treatment to groin puncture
Time frame: day 1
Time from telemedicine-assisted decision for endovascular treatment to initiation of endovascular treatment by groin puncture
7 secondary outcomes
Time from symptom onset to recanalization
Time frame: day 1
Other procedural times of hyperacute care
Time frame: day 1
Recanalization
Time frame: day 1
Symptomatic intracerebral hemorrhage
Time frame: 7 days
In-hospital death or palliative care
Time frame: 7 days
Periprocedural complications
Time frame: day 1
In-hospital complications
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Background: PubMed 27673305Saver 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.
- Background: PubMed 31310296Jahan 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.
- Derived from this study: PubMed 38238050Leitner MA, Hubert GJ, Paternoster L, Leitner MI, Remi JM, Trumm C, Haberl RL, Hubert ND. Clinical outcome of rural in-hospital-stroke patients after interhospital transfer for endovascular therapy within a telemedical stroke network in Germany: a registry-based observational study. BMJ Open. 2024 Jan 18;14(1):e071975. doi: 10.1136/bmjopen-2023-071975.
- Derived from this study: PubMed 33849042Hubert 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.
- TEMPISLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Brain Infarction
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gordian J Hubert, Dr. med. principal investigator
München Klinik gGmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Infarction, run by Munich Municipal Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from decision for endovascular treatment to groin puncture (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04270513, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.