Effect of DIRECT transfer to ANGIOsuite on functional outcome in patient with severe acute stroke treated with thrombectomy

Why the DIRECT ANGIO study?

Problematic

Stroke remains a large cause of death and disability in France and in the world. 1 patient present a stroke every 3 minutes and 75% of them will not be independent at 3 months. Acute ischemic stroke due to the large vessel occlusion (LVO) of the anterior circulation is the most severe form and represent 30% of overall strokes. Endovascular mechanical thrombectomy, in association or not with intravenous thrombolysis is the standard of care for patients with acute ischemic stroke and anterior LVO since 2015.


Patient presenting an acute ischemic stroke due to proximal anterior circulation occlusion. Intravenous thrombolysis and endovascular thrombectomy showing the arterial proximal occlusion. Early successful reperfusion allowing the extension of the ischemic core and the disability.

Context

Endovascular mechanical thrombectomy increases functional independence in patients with acute ischemic stroke caused by anterior circulation large vessel occlusion, and the probability to achieve functional independence decreases by 10% for each 30 minutes delay to reperfusion. Therefore, it is currently crucial to achieve fast triage and initiation of endovascular therapy. To date, patients with a suspected stroke perform first an imaging and secondary transfer to the angiosuite for mechanical thrombectomy if large vessel occlusion is confirmed. This approach results in prolonged delays in delivering definitive therapy in the setting of large vessel occlusion strokes, whereas the angiosuite has imaging facilities to rule out intracranial haemorrhage with the cone beam CT and confirm proximal arterial occlusion by catheter angiogram.

A solution?

Direct admission to the thrombectomy room (without going through MRI or CT) to reduce intra-hospital management delays, and consequently the delay of cerebral reperfusion.
Therefore, we aim to investigate whether direct angiosuite transfer (DAT) is superior to standard imaging/emergency department-based management in achieving 90-day functional independence in patients presenting with an acute severe neurological deficit likely due to LVO and requiring emergent treatment with MT.

How is the study organized?

The study is running in 10 French comprehensive stroke centres to enroll 208 patients overall. On arrival in angiosuite and after rapid neurological examination (using National Institutes of Health Stroke Scale (NIHSS) and mRS scores) and blood sample, the patient undergoes CBCT in order to exclude non-ischaemic stroke and angiogram to confirm LVO.

After inclusion, the patients are randomised in two arms using a web-based centralised system with a 1:1 ratio to either direct angiosuite transfer (DAT) or standard management.

Primary objective

Participant inclusion and exclusion criteria

Inclusion criteria

  • Between 18 and 75 years,
  • Acute severe neurological deficit at hospital admission confirmed by neurologist defined as:
      • Unilateral motor deficit with a score ≥ 5
        • Facial palsy (item 4 NIHSS 0 to 2)
        • Arm (item 5 NIHSS 0 to 4)
        • Leg (item 6 NIHSS 0 to 4)
    • AND
      • Cortical symptom with a score ≥ 1
        • Language (item 9 NIHSS 0 to 3)
        • Extinction (item 11 NIHSS 0 to 2)
  • Prestroke modified Rankin Scale score 0 to 2,
  • Hospital admission ≤ 5hours,
  • Immediate availability of the angioroom and endovascular treatment team at the randomization,
  • Affiliation to/beneficiary of a social regime.

Exclusion criteria

  • Severe allergy to contrast agents,
  • Any terminal illness such that patient would not be expected to survive more than 90 days,
  • Pregnant or breastfeeding women,
  • Consent refusal or opposition of the relatives,
  • Under legal protection.

Participating centres

Sponsor & Funding

DIRECT ANGIO promotor is the Hostpital of Nancy, France.
The study is financed by the General Direction of Healtcare (DGOS) in the 2018 interregional programe (PHRC-i, GIRCI Est) with the amount of 295.990 euros.

More information about the study

Registration on ClinicalTrials.gov (NCT03969511)https://clinicaltrials.gov

Publication of the protocol in BMJ Openhttps://bmjopen.bmj.com

Milestones of DIRECT ANGIO study

Contacts

Coordinating Investigator

Pr. Benjamin GORY
Adress : Service de Neuroradiologie Diagnostique et Thérapeutique, CHRU Nancy – Hôpital Central,
29 Avenue du Maréchal de Lattre de Tassigny, 54035 Nancy
Mail :
Phone : +33 3 83 85 95 27

Referring neurologist

Pr. Sébastien RICHARD
Adress : Service de Neurologie, CHRU Nancy – Hôpital Central,
29 Avenue du Maréchal de Lattre de Tassigny, 54035 NANCY
Mail :
Phone : +33 3 83 85 21 12

Clinical Research Associate (CRA)

Quentin GEROME
Adress : MPI – Délégation à la Recherche Clinique et à l’Innovation (DRCI), CHRU Nancy – Hôpitaux de Brabois, Bâtiment Recherche, RdC,
rue du Morvan, 54511 VANDOEUVRE-LES-NANCY
Mail :
Phone : +33 3 83 15 51 70

Clinical Study Coodinator

Aboubaker CHERIFI
Adress : CIC-IT Nancy – DRCI, CHRU Nancy – Hôpitaux de Brabois, Bâtiment Recherche, RdC,
rue du Morvan, 54511 VANDOEUVRE-LES-NANCY
Mail :
Phone : +33 3 83 15 70 84

Research Vigilence

Dr. Nadine PETITPAIN / Madlyne JACQUOT
Adress : Centre Régional de Pharmacovigilance de Lorraine, CHRU Nancy – Bâtiment de Biologie et de Biopathologie – Hôpitaux de Brabois,
rue du Morvan, 54511 VANDOEUVRE-LES-NANCY
Mail :
Phone : +33 3 83 65 60 90 / 60 91