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DIRECT-SAFE: A Randomized Controlled Trial of DIRECT Endovascular Clot Retrieval Versus Standard Bridging Thrombolysis With Endovascular Clot Retrieval

NCT03494920 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 295

Last updated 2022-06-16

No results posted yet for this study

Summary

The study will be a multicentre, prospective, randomized, open label, blinded endpoint (PROBE) phase 3 trial (2 arm with 1:1 randomization) in ischemic stroke patients within 4.5 hours of stroke onset. Randomised patients will be stratified for site of baseline arterial occlusion into one of three groups: 1. internal carotid artery (ICA) 2. middle cerebral artery (MCA) 3. basilar artery (BA). Patients will be randomised to either bridging intravenous thrombolysis with endovascular clot retrieval (ECR), or direct endovascular clot retrieval.

Conditions

Interventions

OTHER

Direct endovascular clot retrieval

Direct endovascular clot retrieval within 4.5 hours of stroke onset

OTHER

Bridging thrombolysis followed by ECR

Bridging thrombolysis followed by ECR within 4.5 hours of stroke onset

Sponsors & Collaborators

  • The Florey Institute of Neuroscience and Mental Health

    collaborator OTHER

  • Neuroscience Trials Australia

    lead OTHER

Principal Investigators

  • Peter Mitchell, MD · Melbourne Health

  • Bernard Yan, MD · Melbourne Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-27
Primary Completion
2021-09-08
Completion
2021-09-08

Countries

  • Australia
  • China
  • Singapore
  • Vietnam

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03494920 on ClinicalTrials.gov