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

NCT06825897 | Recruiting DMC

• 1 other identifier: 202407139
• Study Type: interventional
• Target: 2,039
• Locations: 1 country
• Sites: 6

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

Keywords

Large Vessel Occlusion; Acute Ischemic Stroke; Pragmatic Clinical Trial

Outcome Measures

Primary Outcomes (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.

  90 days (±14 days)

Secondary Outcomes (5)

• Functional Independence at 90 Days

  90 (±14) days.

• Stroke Workflow Efficiency

  Immediately post procedure

• Procedural Success

  Immediately post-procedure.

• Cognitive Ability

  90 (±14) days.

• Health-Related Quality of Life

  90 (±14) days.

Other Outcomes (6)

• Global Disability

  Immediately at discharge.

• Instrumental Activities of Daily Living

  90 (±14) days.

• Caregiving Burden

  90 (±14) days.

Study Arms (2)

Conventional Triage Arm

ACTIVE COMPARATOR

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.

Other: Conventional Triage for Mechanical Thrombectomy

Direct Transfer to Angiography Suite (DTAS) Arm

ACTIVE COMPARATOR

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.

Other: Direct Transfer to Angiography Suite (DTAS

Interventions

Conventional Triage for Mechanical Thrombectomy OTHER

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.

Conventional Triage Arm

Direct Transfer to Angiography Suite (DTAS OTHER

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.

Direct Transfer to Angiography Suite (DTAS) Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• \. 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:
• \. 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Santiago Ortega Gutierrez: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (6)

University of Iowa

Iowa City, Iowa, 52242, United States

NOT YET RECRUITING

Henry Ford Health System

Detroit, Michigan, 48202, United States

RECRUITING

University of Michigan Health-West

Wyoming, Michigan, 49519, United States

RECRUITING

HMH Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

RECRUITING

The Research Foundation for SUNY on behalf of University at Buffalo

New York, New York, 14203, United States

RECRUITING

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

Related Publications (9)

• 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.

  PMID: 35710313 BACKGROUND

• 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.

  PMID: 29129157 BACKGROUND

• 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.

  PMID: 36571077 BACKGROUND

• 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.

  PMID: 30355182 BACKGROUND

• 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.

  PMID: 28446535 BACKGROUND

• 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.

  PMID: 33938914 BACKGROUND

• 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.

  PMID: 16514102 BACKGROUND

• 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.

  PMID: 36239645 BACKGROUND

• 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.

  PMID: 25882510 BACKGROUND

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Santiago Ortega, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

• Tudor Jovin, MD

  Cooper University Health Care

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Santiago Ortega, MD

CONTACT

319-384-5628; santy-ortega@uiowa.edu

Carlos A Contreras Mesa, MSc

CONTACT

3194992748; carlos-contrerasmesa@uiowa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Data Analysts: Individuals analyzing the data may also be blinded to the treatment assignment to avoid bias in data interpretation
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 13, 2025
• Study Start: January 27, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

US (6)