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

Completed

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

• Registration Number: NCT05503212
• Lead Sponsor: Centre Hospitalier Universitaire Vaudois

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01-01
• Study First Submitted: 2022-03-22
• Study First Submitted QC: 2022-08-15
• Study First Posted: 2022-08-16
• Status Verified: 2023-08
• Primary Completion: 2023-08-09
• Study Completion: 2023-08-09
• Last Update Submitted: 2023-08-09
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 682

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AIS and isolated VAO	Intravenous thrombolysis (IVT)	Patients with acute ischemic stroke (AIS) and concomitant isolated intracranial and/or extracranial vertebral artery occlusion (VAO)
AIS and isolated VAO	Conservative treatment (CT)	Patients with acute ischemic stroke (AIS) and concomitant isolated intracranial and/or extracranial vertebral artery occlusion (VAO)
AIS and isolated VAO	Endovascular thrombectomy (EVT) ± intravenous thrombolysis (IVT)	Patients with acute ischemic stroke (AIS) and concomitant isolated intracranial and/or extracranial vertebral artery occlusion (VAO)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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)
Cerebrovascular ischemic recurrences	90 days	Any ischemic stroke or transient ischemic attack recurrence \[yes/no\]
Symptomatic intracerebral haemorrhage (sICH)	7 days	Any hemorrhagic transformation temporally related to any worsening in neurological condition. \[yes/no\]
24-hour NIHSS	24 hours	NIH Stroke Scale/Score (NIHSS). Quantifies stroke severity based on weighted clinical evaluation findings at 24h. \[0-42, 0= no deficit, 42=maximum stroke severity\]
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)
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. \[yes/no\]
24h and 3month mortality	24h and 90 days	Mortality at 24h and 3 months

Trial Locations

Locations (1)

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, VD, Switzerland