Clinical trial NCT05503212: Best Revascularisation Approach for Posterior Circulation Strokes With Isolated Vertebral Artery Occlusions
Official title: Best Revascularisation Approach for Posterior Circulation Strokes With Isolated Vertebral : the BRAVO Retrospective Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Stroke
Vertebral Artery Ischemia
Arterial Occlusive Diseases
Vertebrobasilar Insufficiency
Keywords: Prognosis
Revascularization
Treatment
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
Collaborators: name: Asan Medical Center
name: St John of God Hospital, Vienna
name: Medical University Innsbruck
name: Hospital Vall d'Hebron
name: University Hospital, Basel, Switzerland
name: Clinical Centre of Serbia
name: Charite University, Berlin, Germany
name: Insel Gruppe AG, University Hospital Bern
name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
name: Boston Medical Center
name: Università degli Studi di Brescia
name: The Cooper Health System
name: University Hospital Carl Gustav Carus
name: Duke University
name: University Hospital, Geneva
name: Hadassah Medical Organization
name: Sahlgrenska University Hospital
name: Universitätsklinikum Hamburg-Eppendorf
name: Helsinki University Central Hospital
name: The University of Texas Health Science Center, Houston
name: University Hospital, Lille
name: Hospital de Egas Moniz
name: Neurocenter of Southern Switzerland
name: Spectrum Health Hospitals
name: Azienda Ospedaliero-Universitaria di Modena
name: Ludwig-Maximilians - University of Munich
name: Azienda USL Reggio Emilia - IRCCS
name: University of Zurich
First posted: 2022-08-16
Enrollment: 682
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with acute ischemic stroke and concomitant isolated vertebral artery occlusion accounting for stroke symptoms

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 randomized clinical trials.


Eligibility criteria: 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

Primary outcomes:
measure: 3-month modified Rankin scale
timeFrame: 90 days
Secondary outcomes:
measure: Symptomatic intracerebral haemorrhage (sICH)
timeFrame: 7 days
measure: EVT procedural complications
timeFrame: During EVT procedure or peri-procedural
measure: 24-hour NIHSS
timeFrame: 24 hours
measure: Early neurological deterioration (ENDi)
timeFrame: 24 hours
measure: Cerebrovascular ischemic recurrences
timeFrame: 90 days
measure: 24h and 3month mortality
timeFrame: 24h and 90 days
measure: Vessel recanalisation on follow up-imaging
timeFrame: 48 hours
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
state: VD
Study officials:
affiliation: CHUV
name: Dr. med. Alexander Salerno, MD
role: PRINCIPAL_INVESTIGATOR
References: