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

Sponsor

Centre Hospitalier Universitaire Vaudois (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05503212

Collaborator

(none)

147

Enrollment

Location

252

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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 cluster-randomized studies or RCT.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Stroke Vertebral Artery Ischemia Arterial Occlusive Diseases Vertebrobasilar Insufficiency	Other: Conservative treatment (CT) Other: Intravenous thrombolysis (IVT) Other: Endovascular thrombectomy (EVT) ± intravenous thrombolysis (IVT)

Study Design

Study Type:

Observational

Actual Enrollment :

147 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2003

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Symptomatic intracerebral haemorrhage (sICH) [7 days]
Any hemorrhagic transformation temporally related to any worsening in neurological condition. [yes/no]
EVT procedural complications [During EVT procedure or peri-procedural]
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)
24-hour NIHSS [24 hours]
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]
Early neurological deterioration (ENDi) [24 hours]
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]
Cerebrovascular ischemic recurrences [90 days]
Any ischemic stroke or transient ischemic attack recurrence [yes/no]
24h and 3month mortality [24h and 90 days]
Mortality at 24h and 3 months
Vessel recanalisation on follow up-imaging [48 hours]
Vessel recanalisation at follow-up imaging (0= no recanalisation, 1= partial recanalisation 50-99%, 2=full recanalisation, 3= initially not occluded)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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