Acute Ischemic Stroke Clinical Trial
— DIRECTANGIOOfficial title:
Effect of DIRECT Transfer to ANGIOsuite on Functional Outcome in Patient With Severe Acute Stroke Treated With Thrombectomy: the Randomized DIRECT ANGIO Trial
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.
Status | Recruiting |
Enrollment | 208 |
Est. completion date | August 9, 2025 |
Est. primary completion date | October 24, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: - 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 1. Facial palsy: item 4 of NIHSS (score 0 to 2) 2. Arm: item 5 of NIHSS (score 0 to 4) 3. Leg: item 6 of NIHSS (score 0 to 2) AND - Cortical symptom with a total score = 1 1. Language: item 9 of NIHSS (score 0 to 3) 2. 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 - Person affiliated to or beneficiary of a social security plan Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
France | Centre Hospitalier Régional Universitaire | Nancy |
Lead Sponsor | Collaborator |
---|---|
Central Hospital, Nancy, France |
France,
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. — View Citation
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. Erratum In: Lancet Neurol. 2016 Nov;15(12):1203. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Confirmed large-vessel occlusion in the intervention group | proportion of arterial occlusive lesion on first angiogram | per-procedural time | |
Secondary | the quality of final perfusion | the modified Treatment In Cerebral Ischemia (mTICI) score, a 5-point scale staged from 0 (no perfusion), 1 ( antegrade reperfusion past the initial occlusion, but limited distal branch filling with little or slow distal reperfusion), 2a (antegrade reperfusion of less than half of the occluded target artery previously ischemic territory), 2b (antegrade reperfusion of more than half of the previously occluded target artery ischemic territory), 2c (nearly complete reperfusion), to 3 (complete antegrade reperfusion of the previously occluded target artery ischemic territory, with absence of visualized occlusion in all distal branches) interpretation of mTICI score: higher is better | at end of the endovascular procedure | |
Secondary | the 24-hour clinical improvement | National Institute of Health Stroke Scale (NIHSS) neurological impairment and its seriousness are scale from 0 (no impairment) to 42 (most serious neurological deficit) interpretation of the NIHSS : lower is better | at 24 hours ((±6 hours) | |
Secondary | the blinded 12-month functional outcome | modified Rankin Scale assessing functional outcome from complete recovery scored 0 to death scored 6 interpretation of mRS : lower is better | at 12 months (±1 month) |
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