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โ† Trials
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Delay AvoIding Primary Evaluation for ThRombectomy of Acute StrokE Patients With Large Vessel OCclusion in the Angiography SuiTe

RecruitingNAAges 18 Years - anyAllSantiago Ortega Gutierrez
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to compare two strategies for treating adults with suspected large vessel occlusion stroke within 7 hours of symptom onset. Researchers will evaluate whether direct transfer to the neurointerventional angiography suite improves recovery and reduces disability compared to the conventional approach of first being evaluated in the emergency department. The study will also assess safety and other health outcomes to guide care for stroke patients.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: To be eligible for participation in the DIRECT trial, an individual must meet all of the following criteria: 1. Age: โ‰ฅ 18 years of age. 2. Clinical Presentation: Present to a participating TSC with signs or symptoms suggestive of acute LVO stroke. 3. Stroke Severity: Baseline NIHSS of 10 or higher. 4. Time since LKW: Time from LKW to arrival at the TSC must be within 7 hours. Additional criteria For all Interfacility Transfers: 1\. If imaging was performed at the outside facility, the time from the first imaging to arrival at the thrombectomy center must exceed 90 minutes. For all the Conventional Triage Arm, participants must also meet the following criteria: 1. Presence of a qualifying LVO by CTA or MRA imaging; or 2. For Large Core Patients: Patients with large core infarcts (CT-ASPECT score โ‰ค 5, DWI-ASPECT score โ‰ค 5, or infarct volume โ‰ฅ 70 cc) will be enrolled, irrespective of treatment decisions regarding embolectomy. For all DTAS Arm: 1\. Patients who do not have LVO occlusions in the angiography suite assessment (ICH, distal occlusions or mimics) will be enrolled, irrespective of treatment decisions regarding embolectomy. Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in the trial: 1. Time Restrictions: Presentation to a thrombectomy-capable center more than 7 hours from LSW. 2. Imaging Criteria for Interfacility Transfer Patients: At sites enrolling transfer patients, any patient arriving from an outside hospital with time from imaging study at the presenting hospital to arrival at the TSC not exceeding 90 minutes. 3. Hemorrhagic Stroke: Presence of intracranial hemorrhage on brain imaging in the conventional strategy as Heidelberg that renders thrombectomy contraindicated.
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What it tests

  • Conventional Triage for Mechanical Thrombectomy
  • Direct Transfer to Angiography Suite (DTAS
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Where

15 sites
Yale New Haven Hospital
New Haven, United States
Memorial Healthcare System
Hollywood, United States
University of Miami/ Jackson Memorial Hospital
Miami, United States
University of Michigan Health-West
Wyoming, United States
Saint Louis University
St Louis, United States
Cooper University Hospital
Camden, United States
HMH Hackensack University Medical Center
Hackensack, United States
Rutgers New Jersey Medical School
Newark, United States

โ€ฆand 7 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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