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

  • STATUS
    Recruiting
  • End date
    May 3, 2021
  • participants needed
    780
  • sponsor
    Neuroscience Trials Australia
Updated on 3 November 2019
Investigator
Bernard Yan, MD
Primary Contact
Royal North Shore Hospital (4.8 mi away) Contact
+25 other location
clot
stroke
arterial occlusion
probe

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.

Description

The DIRECT-SAFE trial will include patients with acute ischemic stroke, who are 18 years of age and are eligible for standard intravenous tPA therapy within 4.5 hours of stroke onset. Patients will be assessed for large vessel occlusion to determine their eligibility for randomization into the trial. Eligible vessel occlusions include the internal carotid artery, basilar artery or middle cerebral artery (M1 or M2). Patients will be consented after large vessel occlusion is confirmed based on standard care multimodal imaging.

Patients will be recruited in Australia, New Zealand, China, Taiwan, Vietnam, Singapore and Europe. Randomisation either direct to ECR or standard thrombolytic therapy and ECR shall be in a 1:1 ratio.

All patients will have a multimodal MR (or CT/CTP at investigator's discretion if MRI not possible) at 18 to 30 hours post treatment to assess reperfusion, recanalization, ischemic core growth and hemorrhagic transformation. Final follow up will occur at Day 90.

Details
Treatment Direct endovascular clot retrieval, Bridging thrombolysis followed by ECR
Clinical Study IdentifierNCT03494920
SponsorNeuroscience Trials Australia
Last Modified on3 November 2019

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Ischemic Stroke?
Patients presenting with acute ischemic stroke eligible using standard criteria to receive IV thrombolysis within 4.5 hours of stroke onset
Patient's age is 18 years
Intra-arterial clot retrieval treatment can commence (groin puncture) within 6 hours of stroke onset
Arterial occlusion on CTA or MRA of the ICA, M1, M2 or basilar artery

Exclusion Criteria

Intracranial hemorrhage (ICH) identified by CT or MRI
Rapidly improving symptoms at the discretion of the investigator
Pre-stroke mRS score of 4 (indicating previous disability)
Hypodensity in >1/3 MCA territory on non-contrast CT
Contra indication to imaging with contrast agents
Any terminal illness such that patient would not be expected to survive more than 1 year
Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study
Pregnant women
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