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

Brain Infarction Clinical Trial

— FIT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04270513
• Other study ID #: FIT
• Status: Active, not recruiting
• Start date: February 1, 2018
• Est. completion date: April 2020

Study information

• Verified date: February 2020
• Source: Munich Municipal Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 477
• Est. completion date: April 2020
• Est. primary completion date: October 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Infarction
• Infarction

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Germany	TEMPiS TeleStroke Network, Department of Neurology, Munich Municipal Hospital	Munich	Bavaria

Sponsors (3)

Lead Sponsor	Collaborator
Munich Municipal Hospital	Technische Universität München, University of Regensburg

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View Citation

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, Castaño C, Sapkota BL, Fransen PS, Molina C, van Oostenbrugge RJ, Chamorro Á, 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time from symptom onset to recanalization	Time from symptom onset to recanalization of previously occluded target artery by endovascular treatment	day 1
Secondary	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	day 1
Secondary	Recanalization	Proportion of patients with antegrade reperfusion of more than half of the previously occluded target artery ischemic territory after endovascular treatment	day 1
Secondary	Symptomatic intracerebral hemorrhage	Proportion of patients with symptomatic intracerebral hemorrhage	7 days
Secondary	In-hospital death or palliative care	In-hospital death or decision for palliative care	7 days
Secondary	Periprocedural complications	Proportion of patients with periprocedural, endovascular treatment associated complications	day 1
Secondary	In-hospital complications	Proportion of patients with other in-hospital complications	7 days

External Links

•   TEMPIS