Best Revascularisation Approach for Posterior Circulation Strokes With Isolated Vertebral Artery Occlusions (BRAVO)

Best Revascularisation Approach for Posterior Circulation Strokes With Isolated Vertebral : the BRAVO Retrospective Analysis

Isolated vertebral artery occlusions (VAO) account for approximately one third of posterior circulation occlusions, but have been given the least attention among posterior circulation strokes. If the two recent ATTENTION and BAOCHE randomized clinical trials have proven the superiority of endovascular thrombectomy (EVT) in basilar artery occlusions, data on the effectiveness and harm of acute revascularization treatment on isolated VAO is scarce. We aim to investigate the impact of acute recanalisation treatments in acute ischemic stroke patients with isolated VAO.

In the absence of RCT, observational data with appropriate statistical methods may give indications on benefits and harms of treating neglected stroke situations like acute vertebral occlusion. Results may also lay the basis for prospective studies, such as randomized clinical trials.

Study Overview

• Status: Completed
• Conditions: Arterial Occlusive Diseases; Ischemic Stroke; Vertebrobasilar Insufficiency; Vertebral Artery Ischemia
• Intervention / Treatment: Other: Conservative treatment (CT); Other: Intravenous thrombolysis (IVT); Other: Endovascular thrombectomy (EVT) ± intravenous thrombolysis (IVT)

• Study Type: Observational
• Enrollment (Actual): 682

Contacts and Locations

Study Locations

• Switzerland
  • VD
    • Lausanne, VD, Switzerland, 1011
      • Centre Hospitalier Universitaire Vaudois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with acute ischemic stroke and concomitant isolated vertebral artery occlusion accounting for stroke symptoms

Description

Inclusion criteria:

• Acute ischemic stroke limited to the posterior circulation
• Presence of uni- or bilateral VAO (intracranial and/or extracranial) on at least one initial imaging study (CTA, MRA, DSA)
• IVT, EVT or bridging-treated stroke patients between 01.01.2003 and 31.12.2021
• ≥ 18 years old

Exclusion criteria

• Extension of the occlusion into the basilar artery
• Presence of a more distal occlusion in the pc (tandem occlusion/multilevel poster circulation occlusions)
• Previously known chronic occlusion of the any segment of the vertebral artery/arteries
• Local ethical/legal conditions in participating center not fulfilled

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

AIS and isolated VAO; Patients with acute ischemic stroke (AIS) and concomitant isolated intracranial and/or extracranial vertebral artery occlusion (VAO)

Other: Conservative treatment (CT); Best medical treatment without intravenous thrombolysis nor endovascular thrombectomy; Other: Intravenous thrombolysis (IVT); Best medical treatment with intravenous thrombolysis but without endovascular thrombectomy; Other: Endovascular thrombectomy (EVT) ± intravenous thrombolysis (IVT); Best medical treatment with endovascular thrombectomy with or without intravenous thrombolysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-month modified Rankin scale	3-month functional outcome, [range: 0-6, 0= no symptoms, 6=death]	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptomatic intracerebral haemorrhage (sICH)	Any hemorrhagic transformation temporally related to any worsening in neurological condition. [yes/no]	7 days
EVT procedural complications	Any complication attributed to the procedure (vessel perforation, vasospasm, dissection, Subarachnoid haemorrhage (SAH)/Intracerebral haemorrhage (ICH), device detachment/misplacement, embolization to new territory, access-site complications, early reocclusion, other)	During EVT procedure or peri-procedural
24-hour NIHSS	NIH Stroke Scale/Score (NIHSS). Quantifies stroke severity based on weighted clinical evaluation findings at 24h. [0-42, 0= no deficit, 42=maximum stroke severity]	24 hours
Early neurological deterioration (ENDi)	Early neurological deterioration of ischemic origin (ENDi) is defined as an increase in National Institute of Health Stroke (NIHSS) score ≥ 4 points or death within 24 hours. [yes/no]	24 hours
Cerebrovascular ischemic recurrences	Any ischemic stroke or transient ischemic attack recurrence [yes/no]	90 days
24h and 3month mortality	Mortality at 24h and 3 months	24h and 90 days
Vessel recanalisation on follow up-imaging	Vessel recanalisation at follow-up imaging (0= no recanalisation, 1= partial recanalisation 50-99%, 2=full recanalisation, 3= initially not occluded)	48 hours

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Vaudois
• Collaborators: The University of Texas Health Science Center, Houston; Charite University, Berlin, Germany; University of Zurich; University Hospital, Geneva; Helsinki University Central Hospital; Hadassah Medical Organization; Duke University; Boston Medical Center; Asan Medical Center; University Hospital, Basel, Switzerland; Ludwig-Maximilians - University of Munich; Sahlgrenska University Hospital, Sweden; Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico; Spectrum Health Hospitals; University Hospital, Lille; Medical University Innsbruck; The Cooper Health System; Universitätsklinikum Hamburg-Eppendorf; Neurocenter of Southern Switzerland; Azienda Ospedaliero-Universitaria di Modena; Azienda Unità Sanitaria Locale Reggio Emilia; St John of God Hospital, Vienna; Università degli Studi di Brescia; Hospital Vall d'Hebron; Clinical Centre of Serbia; University Hospital Carl Gustav Carus; Hospital de Egas Moniz; Insel Gruppe AG, University Hospital Bern
• Investigators: Principal Investigator: Dr. med. Alexander Salerno, MD, CHUV

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2003
• Primary Completion (Actual): August 9, 2023
• Study Completion (Actual): August 9, 2023

Study Registration Dates

• First Submitted: March 22, 2022
• First Submitted That Met QC Criteria: August 15, 2022
• First Posted (Actual): August 16, 2022

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 9, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Treatment; Prognosis; Revascularization
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Stroke; Ischemic Stroke; Ischemia; Arterial Occlusive Diseases; Vertebrobasilar Insufficiency
• Other Study ID Numbers: Stroke-VAO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No