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

NCT05503212 | Completed

• 1 other identifier: Stroke-VAO
• Study Type: observational
• Target: 682
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke; Vertebral Artery Ischemia; Arterial Occlusive Diseases; Vertebrobasilar Insufficiency

Keywords

Prognosis; Revascularization; Treatment

Outcome Measures

Primary Outcomes (1)

• 3-month modified Rankin scale

  3-month functional outcome, \[range: 0-6, 0= no symptoms, 6=death\]

  90 days

Secondary Outcomes (7)

• Symptomatic intracerebral haemorrhage (sICH)

  7 days

• EVT procedural complications

  During EVT procedure or peri-procedural

• 24-hour NIHSS

  24 hours

• Early neurological deterioration (ENDi)

  24 hours

• Cerebrovascular ischemic recurrences

  90 days

Study Arms (1)

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); Other: Intravenous thrombolysis (IVT); Other: Endovascular thrombectomy (EVT) ± intravenous thrombolysis (IVT)

Interventions

Conservative treatment (CT) OTHER

Best medical treatment without intravenous thrombolysis nor endovascular thrombectomy

AIS and isolated VAO

Intravenous thrombolysis (IVT) OTHER

Best medical treatment with intravenous thrombolysis but without endovascular thrombectomy

AIS and isolated VAO

Endovascular thrombectomy (EVT) ± intravenous thrombolysis (IVT) OTHER

Best medical treatment with endovascular thrombectomy with or without intravenous thrombolysis

AIS and isolated VAO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

Ischemic Stroke; Vertebrobasilar Insufficiency; Arterial Occlusive Diseases

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Dr. med. Alexander Salerno, MD

  CHUV

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Researcher, Principal Investigator

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: August 16, 2022
• Study Start: January 1, 2003
• Primary Completion: August 9, 2023
• Study Completion: August 9, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Locations

CH (1)