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

Ischemic Stroke Clinical Trial

— BRAVO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05503212
• Other study ID #: Stroke-VAO
• Status: Completed
• Start date: January 1, 2003
• Est. completion date: August 9, 2023

Study information

• Verified date: August 2023
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 682
• Est. completion date: August 9, 2023
• Est. primary completion date: August 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Ischemia
• Ischemic Stroke
• Stroke
• Vertebrobasilar Insufficiency

Intervention

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

Locations

Country	Name	City	State
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne	VD

Sponsors (29)

Lead Sponsor

Collaborator

Centre Hospitalier Universitaire Vaudois

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

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-month modified Rankin scale	3-month functional outcome, [range: 0-6, 0= no symptoms, 6=death]	90 days
Secondary	Symptomatic intracerebral haemorrhage (sICH)	Any hemorrhagic transformation temporally related to any worsening in neurological condition. [yes/no]	7 days
Secondary	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
Secondary	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
Secondary	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
Secondary	Cerebrovascular ischemic recurrences	Any ischemic stroke or transient ischemic attack recurrence [yes/no]	90 days
Secondary	24h and 3month mortality	Mortality at 24h and 3 months	24h and 90 days
Secondary	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