Efficacy and Security of an Endovascular Treatment as First Choice Procedure Compared With a Standard Intravenous Thrombolytic Therapy Treatment for Patients With Acute Ischemic Stroke Within 4.5 Hours After Onset

Efficacy and Security of an Endovascular Treatment as First Choice Procedure Compared With a Standard Intravenous Thrombolytic Therapy Treatment for Patients With Acute Ischemic Stroke Within 4.5 Hours After Onset: A Prospective Cohorts Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02164357

Acronym

FUN-TPA

Enrollment

124

Registered

2014-06-16

Start date

2012-09-30

Completion date

2015-12-31

Last updated

2015-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Ischaemic Stroke

Keywords

Ischaemic Stroke, Main artery occlusion, Endovascular treatment, Intravenous Thrombolytic Therapy

Brief summary

This study will compare two ways of treatment for acute ischemic stroke: an endovascular treatment (EVT), defined as intraarterial thrombolysis and/or mechanical thrombectomy as a first choice treatment versus intravenous thrombolytic therapy (IVT) only or followed by EVT in patients with acute ischemic stroke due to a main brain artery occlusion within 4.5 hours after onset. Patients treated with IVT only or with IVT followed by EVT will be analyzed separately.

Interventions

PROCEDUREEVT (endovascular treatment )

PROCEDUREIVT (intravenous thrombolytic therapy)

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* 80 or less years old patients with acute stroke produced by a main artery occlusion * NIHSS National Institutes of Health Stroke Scale score greater than 6 (severe neurological impairment) * Patients receiving EVT or IVT within 4.5 hours after onset

Exclusion criteria

* EVT or IVT contraindication * Previous neurological impairment, severe concomitant disease or poor prognosis. * Pregnancy or breastfeeding * Known hypersensitivity to any study drugs * Severe organic disease for which there is not risk compensation.

Design outcomes

Primary

Measure	Time frame
Death within 90 days after onset	90 days
Symptomatic intracranial haemorrhage	7 days

Secondary

Measure	Time frame	Description
Stroke recovery rate after discharge	From onset to discharge	Recovery defined as a 10-fold decrease in NIHSS or NIHSS (7 days after onset or at discharge)
Functional recovery	4.5 hours after onset	Modified Rankin Score (RMS) value

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026