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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.
• Другое 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 initiate

Первичные конечные точки

• Global Disability at 90 Days [Срок оценки: 90 days (±14 days)]

Вторичные конечные точки (5)

• Functional Independence at 90 Days [Срок оценки: 90 (±14) days.]
• Stroke Workflow Efficiency [Срок оценки: Immediately post procedure]
• Procedural Success [Срок оценки: Immediately post-procedure.]
• Cognitive Ability [Срок оценки: 90 (±14) days.]
• Health-Related Quality of Life [Срок оценки: 90 (±14) days.]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 6 центров

• University of Iowa — Iowa City
• Henry Ford Health System — Detroit
• University of Michigan Health-West — Wyoming
• HMH Hackensack University Medical Center — Hackensack
• The Research Foundation for SUNY on behalf of University at Buffalo — New York
• The University of Texas Health Science Center at Houston — Houston

Публикации

• 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
• 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, PMID 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. PMID 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. PMID 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. PMID 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 PMID 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. PMID 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 PMID 36239645

Идентификаторы

NCT: NCT06825897 · 202407139

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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