Recruiting

Direct Transfer vs. Conventional Approach

Sponsor:

Santiago Ortega Gutierrez

Code:

NCT06825897

Conditions

Stroke, Acute

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Conventional Triage for Mechanical Thrombectomy

Direct Transfer to Angiography Suite (DTAS

Study Details

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.

Conditions

Stroke, Acute

Study ID

NCT06825897

Start date

Jan 27, 2026

Status verified date

Mar, 2026

Completion date

Apr 30, 2028

Anticipated

Primary completion date

Apr 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

2039 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Conventional Triage Arm

In this arm, patients with suspected large vessel occlusion (LVO) stroke undergo an initial evaluation in the emergency department (ED), including standard imaging, to confirm eligibility for mechanical thrombectomy (MT). Once eligibility is confirmed, they are transferred to the neurointerventional suite for further treatment. This strategy represents the traditional approach used in many stroke centers and serves as a comparator to the direct transfer strategy. The outcomes measured in this arm will be compared to those in the Direct Transfer to Angiography Suite (DTAS) arm to assess the relative effectiveness and safety of both triage strategies.

active comparator: Direct Transfer to Angiography Suite (DTAS) Arm

Description: In this arm, patients with suspected large vessel occlusion (LVO) stroke are directly transferred to the neurointerventional angiography suite without initial evaluation in the emergency department. Neuroimaging is performed using flat panel CT (FPCT) to confirm treatment eligibility for mechanical thrombectomy (MT). This strategy aims to reduce delays in treatment and improve clinical outcomes by bypassing the emergency department, leading to faster access to thrombectomy. This arm will assess the effectiveness and safety of direct transfer, comparing it to the conventional triage strategy in terms of disability outcomes, safety, and healthcare utilization.

Interventions

Conventional Triage for Mechanical Thrombectomy

Participants undergo the conventional standard-of-care triage process. Upon arrival at the thrombectomy-capable center, patients first undergo an initial evaluation in the emergency department (ED), which includes diagnostic imaging (CT or MRI) to confirm eligibility for mechanical thrombectomy (MT). If the patient is found to have a large vessel occlusion (LVO) suitable for thrombectomy, they are transferred to the neurointerventional suite for treatment.

Direct Transfer to Angiography Suite (DTAS

Patients who arrive at the thrombectomy-capable center (from home, mobile stroke units, or interfacility transfer) are immediately transferred to the neurointerventional suite, bypassing the emergency department (ED). Upon arrival in the neurointerventional suite, initial neuroimaging (typically using flat panel CT or other imaging modalities) is conducted to confirm the presence of a large vessel occlusion (LVO). If the patient is eligible for mechanical thrombectomy (MT), treatment is initiated directly in the angiography suite. This approach aims to reduce delays in care and improve clinical outcomes by providing faster access to thrombectomy treatment.

Primary outcome measure

  • Global Disability at 90 Days [ Time Frame: 90 days (±14 days) ]

Central Contacts and Locations

Central contacts

Locations

Henry Ford Health System

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Principal Investigator:

Alex Chebl, MD

University of Michigan Health-West

Recruiting

Wyoming, Michigan, United States, 49519

Contacts

Principal Investigator:

Fazeel Siddiqui, MD

HMH Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Principal Investigator:

Haralabos Zacharatos, MD

The Research Foundation for SUNY on behalf of University at Buffalo

Recruiting

New York, New York, United States, 14203

Contacts

Principal Investigator:

Adnan Siddiqui, MD

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Alexandra Czap, MD

More Information

Sponsor

Santiago Ortega Gutierrez

Last update posted

Mar 13, 2026

Last verified

Mar, 2026

Keywords

  • Large Vessel Occlusion
  • Acute Ischemic Stroke
  • Pragmatic Clinical Trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Santiago Ortega Gutierrez on 2026-03-13.