NCT06825897 · Santiago Ortega Gutierrez
Delay AvoIding Primary Evaluation for ThRombectomy of Acute StrokE Patients With Large Vessel OCclusion in the Angiography SuiTe
(DIRECT)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- To be eligible for participation in the DIRECT trial, an individual must meet all of the following criteria:
- Age: ≥ 18 years of age.
- Clinical Presentation: Present to a participating TSC with signs or symptoms suggestive of acute LVO stroke.
- Stroke Severity: Baseline NIHSS of 10 or higher.
- 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:
- Presence of a qualifying LVO by CTA or MRA imaging; or
- For Large Core Patients: Patients with large core infarcts (CT-ASPECT score ≤ 5, DWI-ASPECT score ≤ 5, or infarct volume ≥ 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:
- Time Restrictions: Presentation to a thrombectomy-capable center more than 7 hours from LSW.
- 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.
- Hemorrhagic Stroke: Presence of intracranial hemorrhage on brain imaging in the conventional strategy as Heidelberg that renders thrombectomy contraindicated.
Where
- Iowa City, Iowa
- Detroit, Michigan
- Wyoming, Michigan
- Hackensack, New Jersey
- New York, New York
- Houston, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 13, 2026 · Source of record for eligibility and locations