Clinical trial NCT06825897: Delay AvoIding Primary Evaluation for ThRombectomy of Acute StrokE Patients with Large Vessel OCclusion in the Angiography SuiTe
Official title: Delay Avoiding Primary Evaluation for Thrombectomy for Acute Stroke Patients with Large Vessel Occlusion in the Angiography Suite (DIRECT) Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke, Acute
Keywords: Large Vessel Occlusion
Acute Ischemic Stroke
Pragmatic Clinical Trial
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2025-02-13
Enrollment: 2039
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study employs a cluster-randomized crossover design, where thrombectomy-capable stroke centers (clusters) are randomized to adopt one of two standard-of-care triage strategies: direct transfer to the neurointerventional angiography suite or conventional emergency department evaluation. Each cluster transitions between strategies at predefined intervals of two weeks. This design ensures all centers implement both approaches, enabling a robust comparison of clinical outcomes while accommodating site-specific workflows and variability.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Large vessel occlusion (LVO) strokes are among the most severe types of strokes, caused by a blockage in one of the brain's major blood vessels. These strokes can lead to significant disability or death without prompt treatment. Mechanical thrombectomy (MT), a procedure that physically removes the clot, is one of the most effective treatments for LVO strokes. However, there is still uncertainty about the best way to quickly triage and prepare patients for MT to achieve the best outcomes.

This study, called the DIRECT trial, aims to compare two common triage strategies for patients suspected of having an LVO stroke:

Direct transfer to the neurointerventional angiography suite - In this strategy, patients are taken straight to the neurointerventional suite upon arrival at the hospital. Advanced imaging and treatment decisions are made immediately, potentially speeding up treatment.

Conventional evaluation in the emergency department (ED) - In this approach, patients undergo initial evaluation and imaging in the ED before being transferred to the neurointerventional suite if they are eligible for MT.

The main goal of this study is to determine if bypassing the ED and directly transferring patients to the neurointerventional suite leads to better recovery and reduced disability at 90 days compared to the conventional strategy. Researchers will also assess other important outcomes, including safety (such as the risk of brain bleeding), quality of life after the stroke, efficiency of stroke care, and the use of healthcare resources (such as hospital stay length).

The study will include approximately 2,039 adult patients aged 18 and older who are suspected of having an LVO stroke. To participate, patients must arrive at one of the participating thrombectomy-capable stroke centers within 7 hours of symptom onset. These centers are equipped to perform advanced stroke care, including MT.

Participants in the trial will represent a diverse population reflective of the general community affected by stroke. The trial will take place at 20 hospitals across the United States, all with high experience in treating stroke patients. The study will help provide critical insights into which triage strategy offers the best outcomes for patients with LVO strokes and improve future care for these emergencies.

Eligibility criteria: Inclusion Criteria:

To be eligible for participation in the DIRECT trial, an individual must meet all of the following criteria:

1. Age: ≥ 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 ≤ 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:

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.

Primary outcomes:
measure: Global Disability at 90 Days
timeFrame: 90 days (±14 days)
Secondary outcomes:
measure: Functional Independence at 90 Days
timeFrame: 90 (±14) days.
measure: Stroke Workflow Efficiency
timeFrame: Immediately post procedure
measure: Procedural Success
timeFrame: Immediately post-procedure.
measure: Cognitive Ability
timeFrame: 90 (±14) days.
measure: Health-Related Quality of Life
timeFrame: 90 (±14) days.
Other outcomes:
measure: Global Disability
timeFrame: Immediately at discharge.
measure: Instrumental Activities of Daily Living
timeFrame: 90 (±14) days.
measure: Caregiving Burden
timeFrame: 90 (±14) days.
measure: Healthcare Utilization
timeFrame: 90 (±14) days.
measure: Mortality
timeFrame: 90 (±14) days.
measure: Procedural Complications
timeFrame: Immediately post procedure
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Santiago Ortega, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cooper University Health Care
name: Tudor Jovin, MD
role: PRINCIPAL_INVESTIGATOR
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