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

NCT04270513 | Unknown DMC

• 1 other identifier: FIT
• Study Type: observational
• Target: 477
• Locations: 1 country
• Sites: 1

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).

Conditions

Brain Infarction

Keywords

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

Outcome Measures

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

  day 1

Secondary Outcomes (7)

• Time from symptom onset to recanalization

  day 1

• Other procedural times of hyperacute care

  day 1

• Recanalization

  day 1

• Symptomatic intracerebral hemorrhage

  7 days

• In-hospital death or palliative care

  7 days

Study Arms (2)

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

Endovascular treatment by Flying Intervention Team 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 by Flying Intervention Team in primary stroke center

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Munich Municipal Hospital: lead
• Technical University of Munich: collaborator
• University of Regensburg: collaborator

Study Sites (1)

TEMPiS TeleStroke Network, Department of Neurology, Munich Municipal Hospital

Munich, Bavaria, 81545, Germany

Location

Related Publications (4)

• 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.

  PMID: 27673305 BACKGROUND

• 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.

  PMID: 31310296 BACKGROUND

• 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.

  PMID: 38238050 DERIVED

• 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.

  PMID: 33849042 DERIVED

Related Links

• TEMPIS

MeSH Terms

Conditions

Brain Infarction; Stroke

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Gordian J Hubert, Dr. med.

  München Klinik gGmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2018
• First Posted: February 17, 2020
• Study Start: February 1, 2018
• Primary Completion: October 24, 2019
• Study Completion: April 1, 2020
• Last Updated: February 17, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)