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

Munich Municipal Hospital

Status: Unknown

Conditions: Brain Infarction

Treatments: Other: Endovascular treatment by Flying Intervention Team

Study type: Observational

Funder types: Other

Identifiers

NCT04270513

FIT

Details and patient eligibility

About

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).

Full 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.

Enrollment: 477 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

477 participants in 2 patient groups

EVT by Flying Intervention Team in primary stroke center

Description:

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.

Treatment:

Other: Endovascular treatment by Flying Intervention Team

EVT after secondary transfer to comprehensive stroke center

Description:

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.