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Stroke, AcuteDIRECTNCT06825897

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

A study testing Conventional Triage for Mechanical Thrombectomy and Direct Transfer to Angiography Suite (DTAS in people with Stroke, Acute, run by Santiago Ortega Gutierrez at 15 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Acute
What is being tested?
Conventional Triage for Mechanical Thrombectomy and Direct Transfer to Angiography Suite (DTAS
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,039 participants
Where
15 sitesUnited States
Study dates
27 Jan 2026to 30 Apr 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

15 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Santiago Ortega, MD contact

319-384-5628

santy-ortega@uiowa.edu

Carlos A Contreras Mesa, MSc contact

3194992748

carlos-contrerasmesa@uiowa.edu

15 sites in 1 country

United States15 sites, 15 recruiting

  • Cooper University Hospital

    Camden, New Jersey, 08103

    Cait Versella, MS, 8563422000, Versella-Caitlin@CooperHealth.edu

    Daniel Tonetti, MD

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Meredith Robinson, MS, 8437925252, robme@musc.edu

    Sami Al Kasab, MD

    Recruiting

  • Texas Tech University Health Sciences Center El Paso

    El Paso, Texas, 79905

    Israel Alba, 915-215-4616, israel.alba@ttuhsc.edu

    Gustavo Rodriguez, MD

    Recruiting

  • HMH Hackensack University Medical Center

    Hackensack, New Jersey, 07601

    Alexandra Burbelo, 7323217000 ext. 6889, alexandra.burbelo@hmhn.org

    Haralabos Zacharatos, MD

    Recruiting

  • Valley Baptist Medical Center

    Harlingen, Texas, 78550

    Sofia Lopez, 956 389-1124, sofia.lopez@tenethealth.com

    Ameer Hassan, MD

    Recruiting

  • Memorial Healthcare System

    Hollywood, Florida, 33021

    Piret Baldwin, 954 265-4344, pibaldwin@mhs.net

    Brijesh Mehta, MD

    Recruiting

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

    Caroline Dietz, 713-500-3999, preaward@uth.tmc.edu

    Alexandra Czap, MD

    Recruiting

  • University of Miami/ Jackson Memorial Hospital

    Miami, Florida, 33136

    Carolina Castillo, 786-450-8145, mcc2407@miami.edu

    Dileep Yavagal, MD

    Recruiting

  • Yale New Haven Hospital

    New Haven, Connecticut, 06511

    Michael Kampp, 503-807-9977, michael.kampp@yale.edu

    Nils Petersen, MD

    Recruiting

  • The Research Foundation for SUNY on behalf of University at Buffalo

    New York, New York, 14203

    Amy Lagowski, 716-645-4419, Amy.Lagowski@buffalo.edu

    Adnan Siddiqui, MD

    Recruiting

  • Rutgers New Jersey Medical School

    Newark, New Jersey, 07103

    Roxanne Nagurka, 732-546-7427, nagurkrm@njms.rutgers.edu

    Priyank Khandelwal, MD

    Recruiting

  • Texas Stroke Institute

    Plano, Texas, 75075

    Pauline Matheri, 469-659-2407, Pauline.matheri@hcahealthcare.com

    Kim Hyun Woo, MD

    Recruiting

  • Saint Louis University

    St Louis, Missouri, 63104

    Rachel Overberg, (618) 535-7224, Rachel.cadmus@slucare.ssmhealth.com

    Guillermo Linares, MD

    Recruiting

  • ProMedica Toledo Hospital

    Toledo, Ohio, 43606

    Kathryn Scalzo, 419-291-4068, kathryn.scalzo@promedica.org

    Mouhammad Jumaa, MD

    Recruiting

  • University of Michigan Health-West

    Wyoming, Michigan, 49519

    Joan Westendorp, 6162524793, joan.westendorp@umhwest.org

    Fazeel Siddiqui, MD

    Recruiting

Other trials in United States

About this study

Official title: Delay Avoiding Primary Evaluation for Thrombectomy for Acute Stroke Patients With Large Vessel Occlusion in the Angiography Suite (DIRECT) Trial

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.

Read the 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.

Conditions
Stroke, Acute
Being tested
Conventional Triage for Mechanical Thrombectomy, Direct Transfer to Angiography Suite (DTAS
Keywords
Large Vessel Occlusion, Acute Ischemic Stroke, Pragmatic Clinical Trial
Medical subject headings
Stroke, Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conventional Triage for Mechanical ThrombectomyOther

    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 (DTASOther

    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.

Study groups in NCT06825897
Study groupRoleWhat they receive
Conventional Triage ArmActive comparatorIn 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.
Receives: Other: Conventional Triage for Mechanical Thrombectomy
Direct Transfer to Angiography Suite (DTAS) ArmActive comparatorDescription: 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.
Receives: Other: Direct Transfer to Angiography Suite (DTAS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Global Disability at 90 Days

    Global disability will be measured using the disability-weighted modified Rankin Scale (dw-mRS) at 90 days (±14 days) post-stroke. The dw-mRS is a validated tool assessing the severity of disability across seven levels, from no symptoms (0) to severe disability or death (6). This outcome evaluates whether the direct transfer to the angiography suite (DTAS) strategy results in improved functional outcomes compared to the conventional triage strategy.

    Measured: 90 days (±14 days)

Secondary outcomes (5)

  1. Functional Independence at 90 Days

    The proportion of patients achieving functional independence, measured by a dichotomized modified Rankin Scale score (mRS 0-2), assessed during the in-hospital stay and at 90 (±14) days after treatment.

    Measured: 90 (±14) days.

  2. Stroke Workflow Efficiency

    Metrics include door-to-puncture times, door-to-reperfusion times, and rates of intravenous thrombolysis administration, evaluating the time taken to perform key steps in stroke workflow.

    Measured: Immediately post procedure

  3. Procedural Success

    Reperfusion rates of the large vessel occlusion (LVO) using the Extended Thrombolysis in Cerebral Ischemia (eTICI) scale, with successful reperfusion defined as mTICI 2b-3.

    Measured: Immediately post-procedure.

  4. Cognitive Ability

    Assessed at 90 days using the Montreal Cognitive Assessment (MoCA), measuring domains such as memory, attention, and executive function.

    Measured: 90 (±14) days.

  5. Health-Related Quality of Life

    HR-QoL evaluated using PROMIS GH-10 and EQ-5D-5L to assess overall health and well-being at 90 days.

    Measured: 90 (±14) days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2025
  2. Study start27 Jan 2026
  3. Primary completion30 Apr 2028 (estimated)
  4. Study completion30 Apr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
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.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
2,039 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06825897
Sponsor's protocol ID
202407139
Acronym
DIRECT
Status last verified
Oct 2026
First submitted
29 Jan 2025
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Galecio-Castillo M, Vivanco-Suarez J, Zevallos CB, Dajles A, Weng J, Farooqui M, Ribo M, Jovin TG, Ortega-Gutierrez S. Direct to angiosuite strategy versus standard workflow triage for endovascular therapy: systematic review and meta-analysis. J Neurointerv Surg. 2023 Sep;15(e1):e17-e25. doi: 10.1136/neurintsurg-2022-018895. Epub 2022 Jun 16.

    PubMed 35710313

  • Nogueira RG, Jadhav AP, Haussen DC, Bonafe A, Budzik RF, Bhuva P, Yavagal DR, Ribo M, Cognard C, Hanel RA, Sila CA, Hassan AE, Millan M, Levy EI, Mitchell P, Chen M, English JD, Shah QA, Silver FL, Pereira VM, Mehta BP, Baxter BW, Abraham MG, Cardona P, Veznedaroglu E, Hellinger FR, Feng L, Kirmani JF, Lopes DK, Jankowitz BT, Frankel MR, Costalat V, Vora NA, Yoo AJ, Malik AM, Furlan AJ, Rubiera M, Aghaebrahim A, Olivot JM, Tekle WG, Shields R, Graves T, Lewis RJ, Smith WS, Liebeskind DS, Saver JL, Jovin TG; DAWN Trial Investigators. Thrombectomy 6 to 24 Hours after Stroke with a Mismatch between Deficit and Infarct. N Engl J Med. 2018 Jan 4;378(1):11-21. doi: 10.1056/NEJMoa1706442. Epub 2017 Nov 11.

    PubMed 29129157

  • Regenhardt RW, Rosenthal JA, Dmytriw AA, Vranic JE, Bonkhoff AK, Bretzner M, Hirsch JA, Rabinov JD, Stapleton CJ, Patel AB, Singhal AB, Rost NS, Leslie-Mazwi TM, Etherton MR. Direct to angio-suite large vessel occlusion transfers achieve faster arrival-to-puncture times and improved outcomes. Stroke Vasc Interv Neurol. 2022 Nov;2(6):e000327. doi: 10.1161/svin.121.000327. Epub 2022 Jul 5.

    PubMed 36571077

  • Mendez B, Requena M, Aires A, Martins N, Boned S, Rubiera M, Tomasello A, Coscojuela P, Muchada M, Rodriguez-Luna D, Rodriguez-Villatoro N, Juega J, Pagola J, Molina CA, Ribo M. Direct Transfer to Angio-Suite to Reduce Workflow Times and Increase Favorable Clinical Outcome. Stroke. 2018 Nov;49(11):2723-2727. doi: 10.1161/STROKEAHA.118.021989.

    PubMed 30355182

  • Ribo M, Boned S, Rubiera M, Tomasello A, Coscojuela P, Hernandez D, Pagola J, Juega J, Rodriguez N, Muchada M, Rodriguez-Luna D, Molina CA. Direct transfer to angiosuite to reduce door-to-puncture time in thrombectomy for acute stroke. J Neurointerv Surg. 2018 Mar;10(3):221-224. doi: 10.1136/neurintsurg-2017-013038. Epub 2017 Apr 26.

    PubMed 28446535

  • Almekhlafi MA, Goyal M, Dippel DWJ, Majoie CBLM, Campbell BCV, Muir KW, Demchuk AM, Bracard S, Guillemin F, Jovin TG, Mitchell P, White P, Hill MD, Brown S, Saver JL; HERMES Trialists Collaboration. Healthy Life-Year Costs of Treatment Speed From Arrival to Endovascular Thrombectomy in Patients With Ischemic Stroke: A Meta-analysis of Individual Patient Data From 7 Randomized Clinical Trials. JAMA Neurol. 2021 Jun 1;78(6):709-717. doi: 10.1001/jamaneurol.2021.1055.

    PubMed 33938914

  • Ribo M, Alvarez-Sabin J, Montaner J, Romero F, Delgado P, Rubiera M, Delgado-Mederos R, Molina CA. Temporal profile of recanalization after intravenous tissue plasminogen activator: selecting patients for rescue reperfusion techniques. Stroke. 2006 Apr;37(4):1000-4. doi: 10.1161/01.STR.0000206443.96112.d9. Epub 2006 Mar 2.

    PubMed 16514102

  • Jovin TG, Li C, Wu L, Wu C, Chen J, Jiang C, Shi Z, Gao Z, Song C, Chen W, Peng Y, Yao C, Wei M, Li T, Wei L, Xiao G, Yang H, Ren M, Duan J, Liu X, Yang Q, Liu Y, Zhu Q, Shi W, Zhu Q, Li X, Guo Z, Yang Q, Hou C, Zhao W, Ma Q, Zhang Y, Jiao L, Zhang H, Liebeskind DS, Liang H, Jadhav AP, Wen C, Brown S, Zhu L, Ye H, Ribo M, Chang M, Song H, Chen J, Ji X; BAOCHE Investigators. Trial of Thrombectomy 6 to 24 Hours after Stroke Due to Basilar-Artery Occlusion. N Engl J Med. 2022 Oct 13;387(15):1373-1384. doi: 10.1056/NEJMoa2207576.

    PubMed 36239645

  • Jovin TG, Chamorro A, Cobo E, de Miquel MA, Molina CA, Rovira A, San Roman L, Serena J, Abilleira S, Ribo M, Millan M, Urra X, Cardona P, Lopez-Cancio E, Tomasello A, Castano C, Blasco J, Aja L, Dorado L, Quesada H, Rubiera M, Hernandez-Perez M, Goyal M, Demchuk AM, von Kummer R, Gallofre M, Davalos A; REVASCAT Trial Investigators. Thrombectomy within 8 hours after symptom onset in ischemic stroke. N Engl J Med. 2015 Jun 11;372(24):2296-306. doi: 10.1056/NEJMoa1503780. Epub 2015 Apr 17.

    PubMed 25882510

Questions about this trial

What is this clinical trial studying?

A study testing Conventional Triage for Mechanical Thrombectomy and Direct Transfer to Angiography Suite (DTAS in people with Stroke, Acute, run by Santiago Ortega Gutierrez at 15 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Santiago Ortega, MD (319-384-5628, santy-ortega@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Global Disability at 90 Days (time frame: 90 days (±14 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06825897, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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