Effect of DIRECT Transfer to ANGIOsuite on Functional Outcome in Severe Acute Stroke

NCT03969511 | Terminated DMC

• 1 other identifier: 2019-A01454-53
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: Acute large-vessel strokes, requiring endovascular treatment, are currently being managed through radiology department before being transferred to the angiography room. However, patients with severe neurological deficit have demonstrated even greater benefits from recanalization as the symptom onset-to-reperfusion time is shortened to less than 1 hour. Recent pilot study have shown a benefit in reducing management delays with direct admission to the angiography room and subsequently in increasing functional independence at 3 months. Therefore, the aim is to demonstrate the superiority of the direct angio-suite transfer versus the standard management, in terms of 3-month functional independence, in patients strongly suspected of having a severe ischemic stroke related to acute large-vessel occlusion of the anterior circulation, and treated by mechanical thrombectomy ± intravenous thrombolysis. Methods and Design: The DIRECT ANGIO trial is a (PROBE) randomized, multicenter, controlled, open-label, blinded endpoint clinical trial. Study Outcomes: The primary outcome is the rate of patients with 3-month functional independence defined as modified Rankin Scale score ≤2 at 3 months.

Conditions

Acute Ischemic Stroke

Keywords

large-vessel occlusion; reperfusion therapy

Outcome Measures

Primary Outcomes (1)

• 3-month functional independence

  modified Rankin Scale assessing functional outcome from complete recovery scored 0 to death scored 6 with dichotomized outcome: mRS score 0-2 (at least independent for all activities of daily living) versus 3-6 (poor outcome) interpretation of mRS : lower is better

  3 months (±15 days)

Secondary Outcomes (4)

• Confirmed large-vessel occlusion in the intervention group

  per-procedural time

• the quality of final perfusion

  at end of the endovascular procedure

• the 24-hour clinical improvement

  at 24 hours ((±6 hours)

• the blinded 12-month functional outcome

  at 12 months (±1 month)

Study Arms (2)

Direct angio-suite admission

EXPERIMENTAL

Upon arrival in angio-suite and after neurological examination with scoring NIHSS and pre stroke mRS, and performing the blood sample, patient undergoes rotational CBCT in order to exclude intracerebral hemorrhage and cerebral angiography to confirm proximal arterial occlusion. Mechanical thrombectomy is then performed as well as intravenous thrombolysis in the absence of contraindications.

Procedure: direct angio-suite admission

Standard management

ACTIVE COMPARATOR

Arrival is in the MRI/CT-scan room or in the emergency department. Directly after neurological examination and blood sample, patient undergoes imaging and then bridging therapy, mechanical thrombectomy or intravenous thrombolysis alone when indicated.

Procedure: standard management

Interventions

direct angio-suite admission PROCEDURE

Upon arrival in angio-suite and after neurological examination with scoring NIHSS and mRS, and performing the blood sample, patient undergoes rotational CBCT in order to confirm ischemic stroke. Mechanical thrombectomy is the performed as well as intravenous thrombolysis when contraindications are excluded.

Direct angio-suite admission

standard management PROCEDURE

Arrival is in the MRI/CT-scan room or in the emergency department. Directly after neurological examination and blood sample, patient undergoes imaging and then bridging therapy when indicated.

Standard management

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged from 18 to 85 years,
• Rapid neurological examination by the neurologist of the participating centre before randomization,
• Suffered from acute severe neurological deficit at hospital admission confirmed by neurologist defined as:
• Unilateral motor deficit with a total score ≥ 5
• Facial palsy: item 4 of NIHSS (score 0 to 2)
• Arm: item 5 of NIHSS (score 0 to 4)
• Leg: item 6 of NIHSS (score 0 to 2) AND
• Cortical symptom with a total score ≥ 1
• Language: item 9 of NIHSS (score 0 to 3)
• Extinction: item 11 of NIHSS (score 0 to 2)
• Patients who admitted to hospital within 5 hours after symptom onset
• Known onset time of symptom
• Only mothership admissions
• Fully autonomous patient (pre-stroke mRS ≤2)
• Availability of the angio-suite and endovascular treatment team at the randomization

You may not qualify if:

• Severe allergy to iodinated contrast agents,
• Ongoing pregnancy,
• Breastfeeding,
• Consent refusal or opposition of the relatives,
• Individuals under mandatory legal guardianship or unable to consent and whose relatives oppose the research,
• Any conditions that could hamper the 3-month outcome recording

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Centre Hospitalier Régional Universitaire

Nancy, 54035, France

Location

Related Publications (12)

• 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

• Jadhav AP, Kenmuir CL, Aghaebrahim A, Limaye K, Wechsler LR, Hammer MD, Starr MT, Molyneaux BJ, Rocha M, Guyette FX, Martin-Gill C, Ducruet AF, Gross BA, Jankowitz BT, Jovin TG. Interfacility Transfer Directly to the Neuroangiography Suite in Acute Ischemic Stroke Patients Undergoing Thrombectomy. Stroke. 2017 Jul;48(7):1884-1889. doi: 10.1161/STROKEAHA.117.016946. Epub 2017 May 23.

  PMID: 28536177 BACKGROUND

• Spieler JF, Lanoe JL, Amarenco P. Costs of stroke care according to handicap levels and stroke subtypes. Cerebrovasc Dis. 2004;17(2-3):134-42. doi: 10.1159/000075782. Epub 2003 Dec 29.

  PMID: 14707413 BACKGROUND

• Spieler JF, de Pouvourville G. [Cost evaluation of post-stroke outpatient care: results of a mail survey of patients in the Dijon population-based stroke registry]. Presse Med. 2007 Mar;36(3 Pt 1):399-403. doi: 10.1016/j.lpm.2006.08.002. Epub 2007 Jan 25. French.

  PMID: 17257805 BACKGROUND

• Saver JL, Goyal M, van der Lugt A, Menon BK, Majoie CB, Dippel DW, Campbell BC, Nogueira RG, Demchuk AM, Tomasello A, Cardona P, Devlin TG, Frei DF, du Mesnil de Rochemont R, Berkhemer OA, Jovin TG, Siddiqui AH, van Zwam WH, Davis SM, Castano C, Sapkota BL, Fransen PS, Molina C, van Oostenbrugge RJ, Chamorro A, Lingsma H, Silver FL, Donnan GA, Shuaib A, Brown S, Stouch B, Mitchell PJ, Davalos A, Roos YB, Hill MD; HERMES Collaborators. Time to Treatment With Endovascular Thrombectomy and Outcomes From Ischemic Stroke: A Meta-analysis. JAMA. 2016 Sep 27;316(12):1279-88. doi: 10.1001/jama.2016.13647.

  PMID: 27673305 BACKGROUND

• Bracard S, Ducrocq X, Mas JL, Soudant M, Oppenheim C, Moulin T, Guillemin F; THRACE investigators. Mechanical thrombectomy after intravenous alteplase versus alteplase alone after stroke (THRACE): a randomised controlled trial. Lancet Neurol. 2016 Oct;15(11):1138-47. doi: 10.1016/S1474-4422(16)30177-6. Epub 2016 Aug 23.

  PMID: 27567239 BACKGROUND

• Xie Y, Oppenheim C, Guillemin F, Gautheron V, Gory B, Raoult H, Soize S, Felblinger J, Hossu G, Bracard S; THRACE investigators. Pretreatment lesional volume impacts clinical outcome and thrombectomy efficacy. Ann Neurol. 2018 Jan;83(1):178-185. doi: 10.1002/ana.25133.

  PMID: 29314208 BACKGROUND

• Achit H, Soudant M, Hosseini K, Bannay A, Epstein J, Bracard S, Guillemin F; THRACE Investigators. Cost-Effectiveness of Thrombectomy in Patients With Acute Ischemic Stroke: The THRACE Randomized Controlled Trial. Stroke. 2017 Oct;48(10):2843-2847. doi: 10.1161/STROKEAHA.117.017856. Epub 2017 Sep 15.

  PMID: 28916667 BACKGROUND

• Cotte FE, Chaize G, Kachaner I, Gaudin AF, Vainchtock A, Durand-Zaleski I. Incidence and cost of stroke and hemorrhage in patients diagnosed with atrial fibrillation in France. J Stroke Cerebrovasc Dis. 2014 Feb;23(2):e73-83. doi: 10.1016/j.jstrokecerebrovasdis.2013.08.022. Epub 2013 Oct 8.

  PMID: 24119623 BACKGROUND

• Chevreul K, Durand-Zaleski I, Gouepo A, Fery-Lemonnier E, Hommel M, Woimant F. Cost of stroke in France. Eur J Neurol. 2013 Jul;20(7):1094-100. doi: 10.1111/ene.12143. Epub 2013 Apr 8.

  PMID: 23560508 BACKGROUND

• Riou-Comte N, Zhu F, Cherifi A, Richard S, Nace L, Audibert G, Achit H, Costalat V, Arquizan C, Beaufils O, Consoli A, Lapergue B, Loeb T, Rouchaud A, Macian F, Cailloce D, Biondi A, Moulin T, Desmettre T, Marnat G, Sibon I, Combes X, Lebedinsky AP, Vuillemet F, Kempf N, Pierot L, Moulin S, Lemmel P, Mazighi M, Blanc R, Sabben C, Schluck E, Bracard S, Anxionnat R, Guillemin F, Hossu G, Gory B; DIRECT ANGIO Investigators. Direct transfer to angiosuite for patients with severe acute stroke treated with thrombectomy: the multicentre randomised controlled DIRECT ANGIO trial protocol. BMJ Open. 2021 Mar 15;11(3):e040522. doi: 10.1136/bmjopen-2020-040522.

  PMID: 33722864 BACKGROUND

• Gory B, Maier B, Pop R, Wolff V, Soize S, Moulin S, Consoli A, Lapergue B, Costalat V, Arquizan C, Marnat G, Sibon I, Lebedinsky AP, Vuillemet F, Blanc R, Sabben C, Veunac L, Bannier S, Richter JS, Castagnet H, Biondi A, Charbonnier G, Zhu F, Liao L, Anxionnat R, Cherifi A, Achit H, Guillemin F, Hossu G, Richard S; DIRECT ANGIO Investigators. Safety and efficacy of direct versus conventional transfer to angiography suite in patients with severe acute stroke treated with thrombectomy (DIRECT ANGIO) in France: a multicentre, open-label, blinded-endpoint, randomised controlled trial. Lancet Neurol. 2026 Apr;25(4):346-356. doi: 10.1016/S1474-4422(26)00056-6.

  PMID: 41864232 RESULT

Related Links

• Coût de la prise en charge des accidents vasculaires cérébraux en France \[Cost of ischemic stroke management in France\], G. de Pouvourville, 2016

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor (neuroradiologist)

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: May 31, 2019
• Study Start: July 9, 2020
• Primary Completion: July 25, 2023
• Study Completion: April 3, 2024
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)