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

NCT ID: NCT04270513

Last Updated: 2020-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

477 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-01

Study Completion Date

2020-04-30

Brief Summary

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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

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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

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Brain Infarction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Endovascular treatment by Flying Intervention Team

Intervention Type OTHER

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.

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technical University of Munich

OTHER

Sponsor Role collaborator

University of Regensburg

OTHER

Sponsor Role collaborator

Munich Municipal Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gordian J Hubert, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

München Klinik gGmbH

Locations

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TEMPiS TeleStroke Network, Department of Neurology, Munich Municipal Hospital

Munich, Bavaria, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 27673305 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31310296 (View on PubMed)

Leitner 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.

Reference Type DERIVED
PMID: 38238050 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33849042 (View on PubMed)

Related Links

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Other Identifiers

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FIT

Identifier Type: -

Identifier Source: org_study_id

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